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Ignite Creation Date: 2025-12-25 @ 4:42 AM

Ignite Modification Date: 2026-02-27 @ 8:27 AM

Study NCT ID: NCT02663518

Status: TERMINATED

Last Update Posted: 2024-05-10

First Post: 2016-01-19

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626237', 'term': 'TTI-621'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)', 'description': 'Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 milligram per kilogram (mg/kg) infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy', 'description': 'Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 100, 'seriousNumAtRisk': 107, 'deathsNumAffected': 52, 'seriousNumAffected': 43}, {'id': 'EG005', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination', 'description': 'Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL.If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination', 'description': 'Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 34, 'seriousNumAtRisk': 40, 'deathsNumAffected': 27, 'seriousNumAffected': 13}, {'id': 'EG007', 'title': 'Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy', 'description': 'Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 36, 'seriousNumAtRisk': 42, 'deathsNumAffected': 16, 'seriousNumAffected': 15}, {'id': 'EG008', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG011', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 5, 'seriousNumAffected': 3}, {'id': 'EG013', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 39}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 18}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 13}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 28}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 16}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 10}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 44}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 17}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 14}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 28}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 31}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 40, 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'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Intramedullary Rod Insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part 1: Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 1 was 414 days)', 'description': 'An adverse event (AE) was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all the participants who received at least one dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part 1: Day 1 of dosing up to Pre-dose on Day 22', 'description': 'DLT was defined as any of the protocol specified TEAEs that occurred during the 21-day. DLT treatment/observation period (including the pre-dose tests on Day 22/Week 4 Day 1) and that were considered at least possibly related to study treatment by the investigator. Protocol specified DLT TEAE criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding (with the exception of brief, easily-controlled epistaxis, mild gum bleeding or normal menses) or with any requirement for platelet transfusions; Grade 4 anemia, unexplained by underlying disease; Grade 4 neutropenia lasting more than 5 days; Febrile neutropenia of any duration ( Absolute Neutrophil Count (ANC) less than (\\<) 1.0 \\* 10\\^9/L. fever greater than (\\>) 38.5° Degree Celsius (C); Grade 3 or higher non-hematologic toxicity except for alopecia and nausea controlled by medical management; Grade 3 or 4 hemorrhage.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The DLT-evaluable set included participants who had received all 3 doses within the DLT evaluation period, or participants who experienced an AE, meeting DLT criteria during that time. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Part 2 and 3: Number of Participants With TEAEs and TESAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy', 'description': 'Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy', 'description': 'Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination', 'description': 'Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.'}, {'id': 'OG003', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination', 'description': 'Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days)', 'description': 'An AE was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the participants who received at least one dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Part 4: Number of Participants With TEAEs and TESAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG004', 'title': 'Part 4: TTI-621 2 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG005', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part 4: Day 1 of dosing up to 1 year of safety follow-up visit after the last dose (maximum treatment exposure for Part 4 was 667 days)', 'description': 'An AE was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A SAE event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the participants who received at least one dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Part 4: Number of Participants With Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG004', 'title': 'Part 4: TTI-621 2 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG005', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part 4: Day 1 of dosing up to Pre-dose on Day 22', 'description': 'DLT was defined as any of the protocol specified TEAEs that occurred during the 21-day. DLT treatment/observation period (including the pre-dose tests on Day 22/Week 4 Day 1) and that were considered at least possibly related to study treatment by the investigator. Protocol specified DLT TEAE criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding (with the exception of brief, easily-controlled epistaxis, mild gum bleeding or normal menses) or with any requirement for platelet transfusions; Grade 4 anemia, unexplained by underlying disease; Grade 4 neutropenia lasting more than 5 days; Febrile neutropenia of any duration (ANC \\< 1.0 x 109/L, fever \\> 38.5°C); Grade 3 or higher non-hematologic toxicity except for alopecia and nausea controlled by medical management; Grade 3 or 4 hemorrhage.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The DLT-evaluable set included participants who had received all 3 doses within the DLT evaluation period, OR participants who experienced an AE, meeting DLT criteria during that time. As 2.0mg/kg Q2W cohort was not a part of escalation for dose optimization, and not relevant to DLT assessment hence this outcome measure was not analyzed for Q2W arm. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 1: Maximum Plasma Concentration (Cmax) of TTI-621', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '136.594', 'spread': '64.248', 'groupId': 'OG000'}, {'value': '366.636', 'spread': '67.433', 'groupId': 'OG001'}, {'value': '823.137', 'spread': '153.681', 'groupId': 'OG002'}, {'value': '1579.799', 'spread': '518.546', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-evaluable set included treated participants with adequate blood sampling to estimate at least one pharmacokinetic PK parameter.'}, {'type': 'SECONDARY', 'title': 'Part 1: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '1200.722', 'groupId': 'OG000'}, {'value': '6178.488', 'spread': '844.463', 'groupId': 'OG001'}, {'value': '18873.939', 'spread': '6213.503', 'groupId': 'OG002'}, {'value': '36782.700', 'spread': '8700.626', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1', 'unitOfMeasure': 'Nanogram*hour/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable set included treated participants with adequate blood sampling to estimate at least one pharmacokinetic PK parameter. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'timeFrame': 'Part 1: Week 1 end of infusion (EOI)', 'description': 'CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumour cells .', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not analyzed since CD47 data for Part 1 was not collected as the assay was not set up when enrolling the Part 1 participants. Hence, no participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 1: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'title': 'ADA Positive: Overall Incidence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NAb Positive: Overall Incidence', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part 1: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 1 was 414 days)', 'description': 'A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participants had \\>1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \\> \\[4-fold dilution increase\\] in titer from baseline in \\>1 post-treatment sample (treatment-boosted).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity analysis population included all treated participants with at least one ADA sample (pre-dose or post-treatment) analyzed. Here, "Number of Participants Analyzed" signifies number of participants who were ADA or NAb evaluable.'}, {'type': 'SECONDARY', 'title': 'Part 2 and 3 Combined: Maximum Plasma Concentration (Cmax) of TTI-621', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 and 3 Combined: 0.1 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 2 and 3 Combined: 0.2 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 2 and 3 Combined: 0.3 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 2 and 3 Combined: 0.4 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG004', 'title': 'Part 2 and 3 Combined: 0.5 mg/kg', 'description': 'Participants with advanced relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '341', 'spread': '160', 'groupId': 'OG000'}, {'value': '1020', 'spread': '1270', 'groupId': 'OG001'}, {'value': '673', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 2 and 3: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1', 'description': 'Results for this outcome measure was reported for Part 2 and Part 3 combined.', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable set included treated participants with adequate blood sampling to estimate at least one PK parameter. Here, "Number of participants analyzed" signifies number of evaluable participants for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 2 and 3 Combined: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 and 3 Combined: 0.1 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 2 and 3 Combined: 0.2 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 2 and 3 Combined: 0.3 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 2 and 3 Combined: 0.4 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG004', 'title': 'Part 2 and 3 Combined: 0.5 mg/kg', 'description': 'Participants with advanced relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '9330', 'spread': '10300', 'groupId': 'OG000'}, {'value': '20000', 'spread': '10400', 'groupId': 'OG001'}, {'value': '16100', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 2 and 3: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1', 'description': 'Results for this outcome measure was reported for Part 2 and Part 3 combined.', 'unitOfMeasure': 'Nanogram*hour per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK -evaluable set included treated participants with adequate blood sampling to estimate at least one PK parameter. Here, "Number of participants analyzed" signifies number of evaluable participants for this outcome measure. Data for only those arms \\[according to dose\\] are reported for this outcome measure which had any evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Part 2 and 3 Combined: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 and 3 Combined: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 2 and 3 Combined: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.99', 'spread': '16.54', 'groupId': 'OG000'}, {'value': '31.39', 'spread': '17.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 2 and 3: Week 1 end of infusion (EOI)', 'description': 'CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumour cells. Results are reported for combined Part 2 and 3.', 'unitOfMeasure': 'Percentage of Cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all the participants who received at least one dose of study treatment. Here, "Number of participants analyzed" signifies number of evaluable participants for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 2 and 3: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy', 'description': 'Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination', 'description': 'Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL.If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.'}, {'id': 'OG002', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination', 'description': 'Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.'}, {'id': 'OG003', 'title': 'Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy', 'description': 'Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'title': 'ADA Positive: Overall Incidence', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'NAb Positive: Overall Incidence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part 2 and 3: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days)', 'description': 'A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participants had \\>1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \\> 4-fold dilution increase in titer from baseline in \\> 1 post-treatment sample (treatment-boosted).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity analysis population included all treated participants with at least one ADA sample (pre-dose or post-treatment) analyzed. Here, "Number of Participants Analyzed" signifies number of participants who were ADA or NAb evaluable.'}, {'type': 'SECONDARY', 'title': 'Part 2 and 3: Overall Response Rate (ORR) - Lugano Classification (Cheson 2014) and Refinement (Cheson 2016) Disease Indications and Nivolumab/Rituximab Combinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Aggressive B-cell Lymphoma (ABCL)', 'description': 'Participants with ABCL who received study drug in Part 2.'}, {'id': 'OG001', 'title': 'Part 2: Hodgkin Lymphoma (HL)', 'description': 'Participants with HL who received study drug in Part 2.'}, {'id': 'OG002', 'title': 'Part 2: Indolent B-cell Lymphoma (IBCL)', 'description': 'Participants with IBCL who received study drug in Part 2.'}, {'id': 'OG003', 'title': "Part 2: Classical Hodgkin's Lymphoma (cHL)", 'description': 'Participants with cHL who received nivolumab combination in Part 2.'}, {'id': 'OG004', 'title': 'Part 2: CD20-positive Malignancies', 'description': 'Participants with CD20-positive malignancies who received rituximab combination in Part 2.'}, {'id': 'OG005', 'title': 'Parts 2 and 3: Peripheral T-cell Lymphoma (PTCL)', 'description': 'Participants with PTCL who received study drug in Parts 2 and 3.'}, {'id': 'OG006', 'title': 'Parts 2 and 3: T-cell Lymphoma (TCL)', 'description': 'Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': "ORR is presented in this outcome measure as number of responders. Responders were those who had complete remission and partial remission. Lugano classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) were used for tumor response assessment for lymphomas by computed tomography (CT)-based criteria and complete metabolic response (CMR) or partial metabolic response (PMR) by positron emission tomography (PET-CT) based criteria were used for evaluation. Lymphomas evaluated by Lugano Classification include aggressive B-cell lymphoma (ABCL), Hodgkin's lymphoma (HL), Non-Hodgkin's lymphoma, indolent B-cell lymphoma (IBCL), peripheral T-cell lymphoma (PTCL), and part of T-cell lymphoma (TCL).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Parts 2 and 3: Overall Response Rate (ORR)-Olsen 2011-Disease Indication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Parts 2 and 3 : Cutaneous T-cell Lymphoma (CTCL)', 'description': 'Participants with CTCL who received study drug in Parts 2 and 3.'}, {'id': 'OG001', 'title': 'Parts 2 and 3: T-cell Lymphoma (TCL)', 'description': 'Participants with TCL who received study drug and response assessment by Olsen 2011 in Parts 2 and 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'ORR is presented in this outcome measure as number of responders. Responders were those who had complete response and partial response. Clinical endpoints and response criteria (Olsen et al., 2011) for in CTCL (mycosis fungoides and Sezary syndrome) and TCL were used for assessment. Tumor types evaluated included Cutaneous T-cell lymphoma (CTCL) and a part of T-cell lymphoma (TCL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 2: Overall Response Rate (ORR)-Savona 2015- Disease Indication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Myelodysplastic Syndrome (MDS)', 'description': 'Participants with MDS who received study drug in part 2.'}, {'id': 'OG001', 'title': 'Part 2: Myeloproliferative Neoplasms (MPN)', 'description': 'Participants with MPN who received study drug in part 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'ORR is presented in this outcome measure as number of responders. Responders were those who had complete remission, partial remission and marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in adults (Savona et al., 2015) was used for assessment of tumors. Tumor types evaluated include Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 2: Overall Response Rate (ORR)- Hallek 2008- Disease Indication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Chronic Lymphocytic Leukemia (CLL)', 'description': 'Participants with CLL who received study drug in part 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'ORR is presented in this outcome measure as number of responders. Responders were those who had complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines (Hallek et al., 2008) was used for assessment of tumors. Tumor types evaluated include chronic lymphocytic leukemia (CLL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 2: Overall Response Rate (ORR)- Durie 2006- Disease Indication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Multiple Myeloma (MM)', 'description': 'Participants with MM who received study drug in part 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'ORR is presented in this outcome measure as number of responders. Responders were those who had complete response, stringent complete response, very good partial response, partial response. International Uniform Response Criteria for Multiple Myeloma (Durie et al., 2006). was used for assessment of tumors.Tumor types evaluated include Multiple Myeloma (MM).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 2: Overall Response Rate (ORR)- Cheson 2003- Disease Indication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Acute Myeloid Leukemia (AML)', 'description': 'Participants with AML who received study drug in part 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'ORR is presented in this outcome measure as number of responders. Responders were those who had morphologic leukemia-free state, morphologic complete remission, morphologic complete remission with incomplete blood count recovery, partial remission. International Working Group for trials in AML (Cheson et al., 2003) was used for assessment of tumor. Tumor types evaluated include Acute Myeloid Leukemia (AML).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 2: Overall Response Rate (ORR)- Bohnsack 2014- Disease Indication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Small Cell Lung Cancer (SCLC)', 'description': 'Participants with SCLC who received study drug in part 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'ORR is presented in this outcome measure as number of responders. Responders were those who had irComplete Response, IrPartial Response. Immune-Related Response Criteria: RECIST (Bohnsack et al., 2014) was used for assessment of tumor. Tumor types evaluated included Small Cell Lung Cancer (SCLC).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Parts 2 and 3: Duration of Response (DoR)- Disease Indication and Nivolumab/Rituximab Combinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Aggressive B-cell Lymphoma (ABCL)', 'description': 'Participants with ABCL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.'}, {'id': 'OG001', 'title': 'Part 2: Acute Myeloid Leukemia (AML)', 'description': 'Participants with AML who received study drug in Part 2. Response included morphologic leukemia-free state, morphologic complete remission, morphologic complete remission with incomplete blood count recovery, partial remission. International Working Group for trials in AML (Cheson et al., 2003) was used for assessment.'}, {'id': 'OG002', 'title': 'Part 2: Chronic Lymphocytic Leukemia (CLL)', 'description': 'Participants with CLL who received study drug in Part 2. Response included complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines (Hallek et al., 2008) was used for assessment.'}, {'id': 'OG003', 'title': 'Part 2: Hodgkin Lymphoma (HL)', 'description': 'Participants with HL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.'}, {'id': 'OG004', 'title': 'Part 2: Indolent B-cell Lymphoma (IBCL)', 'description': 'Participants with IBCL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.'}, {'id': 'OG005', 'title': 'Part 2: Myelodysplastic Syndrome (MDS)', 'description': 'Participants with MDS who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.'}, {'id': 'OG006', 'title': 'Part 2: Multiple Myeloma (MM)', 'description': 'Participants with MM who received study drug in Part 2. Response included complete response, stringent complete response, very good partial response, partial response. International Uniform Response Criteria for Multiple Myeloma (Durie et al., 2006) was used for assessment.'}, {'id': 'OG007', 'title': 'Part 2: Myeloproliferative Neoplasms (MPN)', 'description': 'Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.'}, {'id': 'OG008', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination', 'description': 'Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.'}, {'id': 'OG009', 'title': 'Part 3: Peripheral T-cell Lymphoma (PTCL)', 'description': 'Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.'}, {'id': 'OG010', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination', 'description': 'Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.'}, {'id': 'OG011', 'title': 'Part 2: Small Cell Lung Cancer (SCLC)', 'description': 'Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.'}, {'id': 'OG012', 'title': 'Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)', 'description': 'Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).'}, {'id': 'OG013', 'title': 'Parts 2 and 3: T-cell Lymphoma (TCL)', 'description': 'Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.3', 'comment': '95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9.2', 'comment': '95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG008', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12.0', 'comment': '95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG009', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.1', 'groupId': 'OG010', 'lowerLimit': '1.9', 'upperLimit': '21.3'}, {'value': '1.9', 'comment': 'Upper limit of 95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG012', 'lowerLimit': '1.8', 'upperLimit': 'NA'}, {'value': '8.3', 'comment': 'Upper limit of 95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG013', 'lowerLimit': '1.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'DoR was defined, in participants who achieved a response as time from the first date of response to the first date of recurrent or progression disease. Participants without recurrent or progression disease were censored on date of the last adequate disease assessment, date of initiation of anticancer treatment or death of death, whichever was the earliest.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Parts 2 and 3: Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}, {'value': '37', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '9', 'groupId': 'OG012'}, {'value': '22', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Aggressive B-cell Lymphoma (ABCL)', 'description': 'Participants with ABCL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.'}, {'id': 'OG001', 'title': 'Part 2: Acute Myeloid Leukemia (AML)', 'description': 'Participants with AML who received study drug in Part 2. Response included morphologic leukemia-free state, morphologic complete remission, morphologic complete remission with incomplete blood count recovery, partial remission. International Working Group for trials in AML (Cheson et al., 2003) was used for assessment.'}, {'id': 'OG002', 'title': 'Part 2: Chronic Lymphocytic Leukemia (CLL)', 'description': 'Participants with CLL who received study drug in Part 2. Response included complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines Chronic lymphocytic leukemia (CLL) Participants with (CLL) NOTE: An Arm/Group Description is shorter than the Arm/Group Title. Response included complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines (Hallek et al., 2008) was used for assessment.'}, {'id': 'OG003', 'title': 'Part 2: Hodgkin Lymphoma (HL)', 'description': 'Participants with HL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.'}, {'id': 'OG004', 'title': 'Part 2: Indolent B-cell Lymphoma (IBCL)', 'description': 'Participants with IBCL who received study drug in Part 2. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.'}, {'id': 'OG005', 'title': 'Part 2: Myelodysplastic Syndrome (MDS)', 'description': 'Participants with MDS who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.'}, {'id': 'OG006', 'title': 'Part 2: Multiple Myeloma (MM)', 'description': 'Participants with MM who received study drug in Part 2. Response included complete response, stringent complete response, very good partial response, partial response. International Uniform Response Criteria for Multiple Myeloma (Durie et al., 2006) was used for assessment.'}, {'id': 'OG007', 'title': 'Part 2: Myeloproliferative Neoplasms (MPN)', 'description': 'Participants with MPN who received study drug in Part 2. Response included complete remission, partial remission, marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in Adults (Savona et al., 2015) was used for assessment.'}, {'id': 'OG008', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination', 'description': 'Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.'}, {'id': 'OG009', 'title': 'Part 3: Peripheral T-cell Lymphoma (PTCL)', 'description': 'Participants with PTCL who received study drug in Part 3. Response included complete remission and partial remission. Lugano Classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) used for assessment.'}, {'id': 'OG010', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination', 'description': 'Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.'}, {'id': 'OG011', 'title': 'Part 2: Small Cell Lung Cancer (SCLC)', 'description': 'Participants with SCLC who received study drug in part 2. Response included irComplete Response, irPartial Response. Immune-Related Response Criteria: irRECIST (Bohnsack et al., 2014) was used for assessment.'}, {'id': 'OG012', 'title': 'Parts 2 and 3: Cutaneous T-cell Lymphoma (CTCL)', 'description': 'Participants with CTCL who received study drug in Parts 2 and 3. Response included complete response, partial response. Clinical endpoints and response criteria (Olsen et al., 2011) were used in CTCL (mycosis fungoides and Sezary syndrome).'}, {'id': 'OG013', 'title': 'Parts 2 and 3: T-cell Lymphoma (TCL)', 'description': 'Participants with TCL who received study drug in Parts 2 and 3. Response included complete remission and partial remission. Response criteria included both Lugano Classification (Cheson 2014/ refinement 2016) and Olsen 2011 used for assessment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'comment': 'Upper limit of 95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': 'NA'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '1.0'}, {'value': '1.4', 'comment': 'Upper limit of 95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': 'NA'}, {'value': '3.1', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '4.4'}, {'value': '1.4', 'comment': 'Upper limit of 95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG004', 'lowerLimit': '0.7', 'upperLimit': 'NA'}, {'value': '0.8', 'comment': 'Upper limit of 95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG005', 'lowerLimit': '0.7', 'upperLimit': 'NA'}, {'value': '1.1', 'groupId': 'OG006', 'lowerLimit': '0.7', 'upperLimit': '1.3'}, {'value': '11.0', 'comment': 'Upper limit of 95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG007', 'lowerLimit': '5.6', 'upperLimit': 'NA'}, {'value': '3.5', 'comment': 'Upper limit of 95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG008', 'lowerLimit': '0.7', 'upperLimit': 'NA'}, {'value': '1.7', 'groupId': 'OG009', 'lowerLimit': '1.5', 'upperLimit': '3.1'}, {'value': '1.7', 'groupId': 'OG010', 'lowerLimit': '1.5', 'upperLimit': '2.3'}, {'value': '5.4', 'groupId': 'OG012', 'lowerLimit': '1.9', 'upperLimit': '10.8'}, {'value': '2.6', 'groupId': 'OG013', 'lowerLimit': '1.6', 'upperLimit': '15.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'PFS was defined as the number of weeks from the date of the first dose of study drug to the earliest of documented recurrent or progressive disease or death due to any cause without prior progression. The progression or censoring date was determined based on described conventions (Food and Drug Administration, 2007). Kaplan-Meier method was used.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 4: Maximum Plasma Concentration (Cmax) of TTI-621', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG004', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG005', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '4040', 'spread': '110', 'groupId': 'OG000'}, {'value': '6190', 'spread': '1100', 'groupId': 'OG001'}, {'value': '10000', 'spread': '4400', 'groupId': 'OG002'}, {'value': '15400', 'spread': '2470', 'groupId': 'OG003'}, {'value': '23600', 'spread': '4530', 'groupId': 'OG004'}, {'value': '18800', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 4: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK)-evaluable Set consists of treated participants with adequate blood sampling to estimate at least one pharmacokinetic PK parameter. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 4: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG004', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG005', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '88800', 'spread': '12300', 'groupId': 'OG000'}, {'value': '116000', 'spread': '38800', 'groupId': 'OG001'}, {'value': '212000', 'spread': '85700', 'groupId': 'OG002'}, {'value': '383000', 'spread': '49600', 'groupId': 'OG003'}, {'value': '638000', 'spread': '120000', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 4: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1', 'unitOfMeasure': 'Nanogram*hour per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK -evaluable set included treated participants with adequate blood sampling to estimate at least one PK parameter. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 4: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG004', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG005', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.25', 'spread': '12.65', 'groupId': 'OG000'}, {'value': '65.49', 'spread': '24.80', 'groupId': 'OG001'}, {'value': '37.17', 'spread': '32.93', 'groupId': 'OG002'}, {'value': '57.09', 'spread': '23.72', 'groupId': 'OG003'}, {'value': '65.00', 'spread': '5.97', 'groupId': 'OG004'}, {'value': '49.51', 'spread': '10.83', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 4: Week 1 end of infusion (EOI)', 'description': 'CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumor cells.', 'unitOfMeasure': 'Percentage of cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all the participants who received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 4: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG004', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG005', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'title': 'ADA Positive: Overall Incidence', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'NAb Positive: Overall Incidence', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part 4: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 4 was 667 days)', 'description': 'A participant was ADA (or NAb) positive if: (1) baseline titer is missing or negative and participants had \\>1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \\> \\[4-fold dilution increase\\] in titer from baseline in \\> 1 post-treatment sample (treatment-boosted).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity analysis population includes all treated participants with at least one (ADA) Anti-Drug Antibody sample (pre-dose or post-treatment) analyzed. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 4: Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG004', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG005', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)', 'description': "ORR is presented in this outcome measure as number of responders. Responders were those who had complete response, partial response. Lymphomas evaluated include Non-Hodgkin's Lymphoma. Clinical endpoints and response criteria in mycosis fungoides and Sezary syndrome (Olsen et al., 2011).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the participants who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Part 4: Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG001', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG002', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG003', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG004', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'OG005', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be estimated due to less number of participants with events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)', 'description': 'DoR was defined, in participants who achieved a response as time from the first date of response to the first date of recurrent or progression disease. Participants without recurrent or progression disease were censored on date of the last adequate disease assessment, date of initiation of anticancer treatment or death of death, whichever was the earliest.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the participants who received at least one dose of study treatment. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part 4: Overall Response Rate (ORR) in Cutaneous T-Cell Lymphoma (CTCL) Both Fungoides and Sezary Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 4: CTCL', 'description': 'Participants with CTCL who received study drug in part 4.'}], 'timeFrame': 'From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)', 'description': 'ORR is presented in this outcome measure as number of responders.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure is not available as analysis was not performed because: 1) due to futility and heterogenicity of respective data of the parameters of organ system (i.e., skin, blood, lymph node, and viscera; 2) the Olsen 2011 criteria already defined the "Global Response Score" to determine the Global Response (GR) consisting of the 4 components which (GR) was more important assessment affecting overall prognosis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 milligram per kilogram (mg/kg) infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'FG001', 'title': 'Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'FG002', 'title': 'Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'FG003', 'title': 'Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'FG004', 'title': 'Ontorpacept (PF-07901800/TTI-621) Monotherapy for Part 2', 'description': 'Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'FG005', 'title': 'Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination', 'description': "Participants with Classical Hodgkin's Lymphoma (cHL) received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen."}, {'id': 'FG006', 'title': 'Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination', 'description': 'Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 milligram per meter square (mg/m\\^2) rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.'}, {'id': 'FG007', 'title': 'Ontorpacept (PF-07901800/TTI-621) Monotherapy for Part 3', 'description': 'Participants with cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL), received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'FG008', 'title': 'Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'FG009', 'title': 'Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'FG010', 'title': 'Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'FG011', 'title': 'Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'FG012', 'title': 'Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'FG013', 'title': 'Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}], 'periods': [{'title': 'Part 1: Phase 1a Escalation', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Part 1 participants.', 'groupId': 'FG000', 'numSubjects': '3'}, {'comment': 'Part 1 participants.', 'groupId': 'FG001', 'numSubjects': '3'}, {'comment': 'Part 1 participants.', 'groupId': 'FG002', 'numSubjects': '7'}, {'comment': 'Part 1 participants.', 'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Informed Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}]}, {'title': 'Part 2 and 3: Phase 1b Expansion', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'No participants for part 2 and 3.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'No participants for part 2 and 3.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'No participants for part 2 and 3.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'No participants for part 2 and 3.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Part 2 participants.', 'groupId': 'FG004', 'numSubjects': '107'}, {'comment': 'Part 2 participants.', 'groupId': 'FG005', 'numSubjects': '11'}, {'comment': 'Part 2 participants.', 'groupId': 'FG006', 'numSubjects': '40'}, {'comment': 'Part 3 participants.', 'groupId': 'FG007', 'numSubjects': '42'}, {'comment': 'No participants for part 2 and 3.', 'groupId': 'FG008', 'numSubjects': '0'}, {'comment': 'No participants for part 2 and 3.', 'groupId': 'FG009', 'numSubjects': '0'}, {'comment': 'No participants for part 2 and 3.', 'groupId': 'FG010', 'numSubjects': '0'}, {'comment': 'No participants for part 2 and 3.', 'groupId': 'FG011', 'numSubjects': '0'}, {'comment': 'No participants for part 2 and 3.', 'groupId': 'FG012', 'numSubjects': '0'}, {'comment': 'No participants for part 2 and 3.', 'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '29'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '15'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '78'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '34'}, {'groupId': 'FG007', 'numSubjects': '27'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '50'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '25'}, {'groupId': 'FG007', 'numSubjects': '16'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Informed Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Study Terminated By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}]}, {'title': 'Part 4: Phase 1b Dose Optimization', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'No participants for part 4.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'No participants for part 4.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'No participants for part 4.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'No participants for part 4.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'No participants for part 4.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'No participants for part 4.', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'No participants for part 4.', 'groupId': 'FG006', 'numSubjects': '0'}, {'comment': 'No participants for part 4.', 'groupId': 'FG007', 'numSubjects': '0'}, {'comment': 'Part 4 participants.', 'groupId': 'FG008', 'numSubjects': '3'}, {'comment': 'Part 4 participants.', 'groupId': 'FG009', 'numSubjects': '3'}, {'comment': 'Part 4 participants.', 'groupId': 'FG010', 'numSubjects': '6'}, {'comment': 'Part 4 participants.', 'groupId': 'FG011', 'numSubjects': '3'}, {'comment': 'Part 4 participants.', 'groupId': 'FG012', 'numSubjects': '12'}, {'comment': 'Part 4 participants.', 'groupId': 'FG013', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '4'}, {'groupId': 'FG013', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '8'}, {'groupId': 'FG013', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '5'}, {'groupId': 'FG013', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Informed Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 249 participants were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '107', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}, {'value': '42', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '12', 'groupId': 'BG012'}, {'value': '4', 'groupId': 'BG013'}, {'value': '249', 'groupId': 'BG014'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 milligram per kilogram (mg/kg) infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'BG001', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'BG002', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'BG003', 'title': 'Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg', 'description': 'Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'BG004', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy', 'description': 'Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'BG005', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination', 'description': 'Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL.If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.'}, {'id': 'BG006', 'title': 'Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination', 'description': 'Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.'}, {'id': 'BG007', 'title': 'Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy', 'description': 'Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'BG008', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'BG009', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'BG010', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'BG011', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'BG012', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'BG013', 'title': 'Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg', 'description': 'Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.'}, {'id': 'BG014', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '< 65 Years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '7', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '130', 'groupId': 'BG014'}]}, {'title': '65 - < 75 Years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '74', 'groupId': 'BG014'}]}, {'title': '75 - < 85 Years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '43', 'groupId': 'BG014'}]}, {'title': '>= 85 Years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '2', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '96', 'groupId': 'BG014'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '24', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '10', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '153', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '26', 'groupId': 'BG014'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}, {'value': '32', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '209', 'groupId': 'BG014'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '14', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '14', 'groupId': 'BG014'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '28', 'groupId': 'BG014'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}, {'value': '30', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '9', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '191', 'groupId': 'BG014'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '15', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population included all the participants who received at least one dose of study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-20', 'size': 1887143, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-20T13:36', 'hasProtocol': True}, {'date': '2022-11-02', 'size': 1143713, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-20T13:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase 1a/1b trial of PF-07901800 (TTI-621) for relapsed or refractory hematologic malignancies and selected solid tumors were conducted in 4 parts. In the dose escalation phase (Part 1), advanced lymphomas were enrolled in sequential dose cohorts for safety, tolerability, PK, and MTD. In the expansion phase (Part 2), subjects with various hematologic malignancies and selected solid tumors were treated at recommended dose determined in phase 1a (Part 1) for safety and efficacy. In the expansion phase (Part 3), 2 cohorts (cutaneous T-cell lymphoma and peripheral T-cell lymphoma) were evaluated for potentially further studied using Simon 2-stage design. In the phase 1b dose optimization (Part 4), further dose escalation was investigated in patients with relapsed and/or refractory CTCL following a 3+3 escalation and revised DLT criteria.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'whyStopped': "Pfizer decided terminating study for administrative reasons on 22Mar2022 (stopping enrollment as of 15Apr2022). The decision wasn't due to safety concerns or requests from regulatory authorities.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2016-01-19', 'resultsFirstSubmitDate': '2023-11-20', 'studyFirstSubmitQcDate': '2016-01-25', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-20', 'studyFirstPostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'Part 1: Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 1 was 414 days)', 'description': 'An adverse event (AE) was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Part 1: Day 1 of dosing up to Pre-dose on Day 22', 'description': 'DLT was defined as any of the protocol specified TEAEs that occurred during the 21-day. DLT treatment/observation period (including the pre-dose tests on Day 22/Week 4 Day 1) and that were considered at least possibly related to study treatment by the investigator. Protocol specified DLT TEAE criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding (with the exception of brief, easily-controlled epistaxis, mild gum bleeding or normal menses) or with any requirement for platelet transfusions; Grade 4 anemia, unexplained by underlying disease; Grade 4 neutropenia lasting more than 5 days; Febrile neutropenia of any duration ( Absolute Neutrophil Count (ANC) less than (\\<) 1.0 \\* 10\\^9/L. fever greater than (\\>) 38.5° Degree Celsius (C); Grade 3 or higher non-hematologic toxicity except for alopecia and nausea controlled by medical management; Grade 3 or 4 hemorrhage.'}, {'measure': 'Part 2 and 3: Number of Participants With TEAEs and TESAEs', 'timeFrame': 'Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days)', 'description': 'An AE was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Part 4: Number of Participants With TEAEs and TESAEs', 'timeFrame': 'Part 4: Day 1 of dosing up to 1 year of safety follow-up visit after the last dose (maximum treatment exposure for Part 4 was 667 days)', 'description': 'An AE was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A SAE event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Part 4: Number of Participants With Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Part 4: Day 1 of dosing up to Pre-dose on Day 22', 'description': 'DLT was defined as any of the protocol specified TEAEs that occurred during the 21-day. DLT treatment/observation period (including the pre-dose tests on Day 22/Week 4 Day 1) and that were considered at least possibly related to study treatment by the investigator. Protocol specified DLT TEAE criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding (with the exception of brief, easily-controlled epistaxis, mild gum bleeding or normal menses) or with any requirement for platelet transfusions; Grade 4 anemia, unexplained by underlying disease; Grade 4 neutropenia lasting more than 5 days; Febrile neutropenia of any duration (ANC \\< 1.0 x 109/L, fever \\> 38.5°C); Grade 3 or higher non-hematologic toxicity except for alopecia and nausea controlled by medical management; Grade 3 or 4 hemorrhage.'}], 'secondaryOutcomes': [{'measure': 'Part 1: Maximum Plasma Concentration (Cmax) of TTI-621', 'timeFrame': 'Part 1: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1'}, {'measure': 'Part 1: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621', 'timeFrame': 'Part 1: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1'}, {'measure': 'Part 1: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells', 'timeFrame': 'Part 1: Week 1 end of infusion (EOI)', 'description': 'CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumour cells .'}, {'measure': 'Part 1: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)', 'timeFrame': 'Part 1: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 1 was 414 days)', 'description': 'A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participants had \\>1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \\> \\[4-fold dilution increase\\] in titer from baseline in \\>1 post-treatment sample (treatment-boosted).'}, {'measure': 'Part 2 and 3 Combined: Maximum Plasma Concentration (Cmax) of TTI-621', 'timeFrame': 'Part 2 and 3: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1', 'description': 'Results for this outcome measure was reported for Part 2 and Part 3 combined.'}, {'measure': 'Part 2 and 3 Combined: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621', 'timeFrame': 'Part 2 and 3: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1', 'description': 'Results for this outcome measure was reported for Part 2 and Part 3 combined.'}, {'measure': 'Part 2 and 3 Combined: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells', 'timeFrame': 'Part 2 and 3: Week 1 end of infusion (EOI)', 'description': 'CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumour cells. Results are reported for combined Part 2 and 3.'}, {'measure': 'Part 2 and 3: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)', 'timeFrame': 'Part 2 and 3: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days)', 'description': 'A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participants had \\>1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \\> 4-fold dilution increase in titer from baseline in \\> 1 post-treatment sample (treatment-boosted).'}, {'measure': 'Part 2 and 3: Overall Response Rate (ORR) - Lugano Classification (Cheson 2014) and Refinement (Cheson 2016) Disease Indications and Nivolumab/Rituximab Combinations', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': "ORR is presented in this outcome measure as number of responders. Responders were those who had complete remission and partial remission. Lugano classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) were used for tumor response assessment for lymphomas by computed tomography (CT)-based criteria and complete metabolic response (CMR) or partial metabolic response (PMR) by positron emission tomography (PET-CT) based criteria were used for evaluation. Lymphomas evaluated by Lugano Classification include aggressive B-cell lymphoma (ABCL), Hodgkin's lymphoma (HL), Non-Hodgkin's lymphoma, indolent B-cell lymphoma (IBCL), peripheral T-cell lymphoma (PTCL), and part of T-cell lymphoma (TCL)."}, {'measure': 'Parts 2 and 3: Overall Response Rate (ORR)-Olsen 2011-Disease Indication', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'ORR is presented in this outcome measure as number of responders. Responders were those who had complete response and partial response. Clinical endpoints and response criteria (Olsen et al., 2011) for in CTCL (mycosis fungoides and Sezary syndrome) and TCL were used for assessment. Tumor types evaluated included Cutaneous T-cell lymphoma (CTCL) and a part of T-cell lymphoma (TCL).'}, {'measure': 'Part 2: Overall Response Rate (ORR)-Savona 2015- Disease Indication', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'ORR is presented in this outcome measure as number of responders. Responders were those who had complete remission, partial remission and marrow response. International Consortium Proposal of Uniform Response Criteria for Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) in adults (Savona et al., 2015) was used for assessment of tumors. Tumor types evaluated include Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN).'}, {'measure': 'Part 2: Overall Response Rate (ORR)- Hallek 2008- Disease Indication', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'ORR is presented in this outcome measure as number of responders. Responders were those who had complete response or complete remission, complete response or complete remission with incomplete marrow recovery, partial response. International Workshop on CLL update of the NCI 1996 Guidelines (Hallek et al., 2008) was used for assessment of tumors. Tumor types evaluated include chronic lymphocytic leukemia (CLL).'}, {'measure': 'Part 2: Overall Response Rate (ORR)- Durie 2006- Disease Indication', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'ORR is presented in this outcome measure as number of responders. Responders were those who had complete response, stringent complete response, very good partial response, partial response. International Uniform Response Criteria for Multiple Myeloma (Durie et al., 2006). was used for assessment of tumors.Tumor types evaluated include Multiple Myeloma (MM).'}, {'measure': 'Part 2: Overall Response Rate (ORR)- Cheson 2003- Disease Indication', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'ORR is presented in this outcome measure as number of responders. Responders were those who had morphologic leukemia-free state, morphologic complete remission, morphologic complete remission with incomplete blood count recovery, partial remission. International Working Group for trials in AML (Cheson et al., 2003) was used for assessment of tumor. Tumor types evaluated include Acute Myeloid Leukemia (AML).'}, {'measure': 'Part 2: Overall Response Rate (ORR)- Bohnsack 2014- Disease Indication', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'ORR is presented in this outcome measure as number of responders. Responders were those who had irComplete Response, IrPartial Response. Immune-Related Response Criteria: RECIST (Bohnsack et al., 2014) was used for assessment of tumor. Tumor types evaluated included Small Cell Lung Cancer (SCLC).'}, {'measure': 'Parts 2 and 3: Duration of Response (DoR)- Disease Indication and Nivolumab/Rituximab Combinations', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'DoR was defined, in participants who achieved a response as time from the first date of response to the first date of recurrent or progression disease. Participants without recurrent or progression disease were censored on date of the last adequate disease assessment, date of initiation of anticancer treatment or death of death, whichever was the earliest.'}, {'measure': 'Parts 2 and 3: Progression Free Survival (PFS)', 'timeFrame': 'From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)', 'description': 'PFS was defined as the number of weeks from the date of the first dose of study drug to the earliest of documented recurrent or progressive disease or death due to any cause without prior progression. The progression or censoring date was determined based on described conventions (Food and Drug Administration, 2007). Kaplan-Meier method was used.'}, {'measure': 'Part 4: Maximum Plasma Concentration (Cmax) of TTI-621', 'timeFrame': 'Part 4: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1'}, {'measure': 'Part 4: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621', 'timeFrame': 'Part 4: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1'}, {'measure': 'Part 4: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells', 'timeFrame': 'Part 4: Week 1 end of infusion (EOI)', 'description': 'CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumor cells.'}, {'measure': 'Part 4: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)', 'timeFrame': 'Part 4: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 4 was 667 days)', 'description': 'A participant was ADA (or NAb) positive if: (1) baseline titer is missing or negative and participants had \\>1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \\> \\[4-fold dilution increase\\] in titer from baseline in \\> 1 post-treatment sample (treatment-boosted).'}, {'measure': 'Part 4: Overall Response Rate (ORR)', 'timeFrame': 'From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)', 'description': "ORR is presented in this outcome measure as number of responders. Responders were those who had complete response, partial response. Lymphomas evaluated include Non-Hodgkin's Lymphoma. Clinical endpoints and response criteria in mycosis fungoides and Sezary syndrome (Olsen et al., 2011)."}, {'measure': 'Part 4: Duration of Response (DoR)', 'timeFrame': 'From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)', 'description': 'DoR was defined, in participants who achieved a response as time from the first date of response to the first date of recurrent or progression disease. Participants without recurrent or progression disease were censored on date of the last adequate disease assessment, date of initiation of anticancer treatment or death of death, whichever was the earliest.'}, {'measure': 'Part 4: Overall Response Rate (ORR) in Cutaneous T-Cell Lymphoma (CTCL) Both Fungoides and Sezary Syndrome', 'timeFrame': 'From first dose of study till the progressive disease/death or withdrawal (maximum observation 6 years 10 months)', 'description': 'ORR is presented in this outcome measure as number of responders.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PF-07901800', 'ABCL', 'Aggressive B-cell lymphoma', 'CLL', 'Chronic lymphocytic leukemia', 'CTCL', 'Cutaneous T-Cell Lymphoma', 'HL', 'Hodgkin lymphoma', 'IBCL', 'Indolent B-cell lymphoma', 'MDS', 'Myelodysplastic syndromes', 'MPN', 'Myeloproliferative neoplasms', 'MM', 'Multiple Myeloma', 'PTCL', 'Peripheral T-cell lymphomas', 'SCLC', 'Small Cell Lung Cancer', 'T-cell lymphoma', 'Rituximab', 'Nivolumab', 'TTI-621', 'Solid Tumor', 'Hematologic Malignancies', 'Lymphoma', 'CD47', 'SIRPα-IgG1 Fc'], 'conditions': ['Hematologic Malignancies', 'Solid Tumor']}, 'referencesModule': {'references': [{'pmid': '36841672', 'type': 'DERIVED', 'citation': 'Marks JA, Wang X, Fenu EM, Bagg A, Lai C. TP53 in AML and MDS: The new (old) kid on the block. Blood Rev. 2023 Jul;60:101055. doi: 10.1016/j.blre.2023.101055. Epub 2023 Feb 14.'}, {'pmid': '33451977', 'type': 'DERIVED', 'citation': "Ansell SM, Maris MB, Lesokhin AM, Chen RW, Flinn IW, Sawas A, Minden MD, Villa D, Percival MM, Advani AS, Foran JM, Horwitz SM, Mei MG, Zain J, Savage KJ, Querfeld C, Akilov OE, Johnson LDS, Catalano T, Petrova PS, Uger RA, Sievers EL, Milea A, Roberge K, Shou Y, O'Connor OA. Phase I Study of the CD47 Blocker TTI-621 in Patients with Relapsed or Refractory Hematologic Malignancies. Clin Cancer Res. 2021 Apr 15;27(8):2190-2199. doi: 10.1158/1078-0432.CCR-20-3706. Epub 2021 Jan 15."}, {'pmid': '30962222', 'type': 'DERIVED', 'citation': "Johnson LDS, Banerjee S, Kruglov O, Viller NN, Horwitz SM, Lesokhin A, Zain J, Querfeld C, Chen R, Okada C, Sawas A, O'Connor OA, Sievers EL, Shou Y, Uger RA, Wong M, Akilov OE. Targeting CD47 in Sezary syndrome with SIRPalphaFc. Blood Adv. 2019 Apr 9;3(7):1145-1153. doi: 10.1182/bloodadvances.2018030577."}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=TTI-621-01', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Multicenter, open-label, phase 1a/1b trial of PF-07901800 (TTI-621) in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.', 'detailedDescription': 'This is a trial of PF-07901800 (TTI-621) in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.\n\nTTI-621 (SIRPαFc) is a soluble recombinant fusion protein created by directly linking the sequences encoding the N-terminal CD47 binding domain of human SIRPα with the Fc domain of human immunoglobulin (IgG1). TTI-621 acts by binding human CD47 and preventing it from delivering an inhibitory "do not eat" (anti phagocytic) signal to macrophages.\n\nThis trial will be conducted in 2 phases and 4 parts: Phase 1a Part 1 (escalation phase) and Phase 1b Parts 2-4 (expansion phase).\n\nIn the dose Escalation Phase (phase 1a Part 1), subjects with lymphoma will be enrolled in sequential dose cohorts to receive TTI-621 to characterize safety, tolerability, pharmacokinetics, and the maximum-tolerated dose (MTD).\n\nIn the Expansion Phase (phase 1b Parts 2-4), TTI-621 will be given to subjects with a variety of hematologic malignancies and selected solid tumors to further define safety and to characterize efficacy. In the Expansion Phase Part 2, the safety and efficacy of TTI-621 will also be assessed when it is given in combination with other anti-cancer drugs. The dose of TTI-621 to be delivered in the Expansion Phase Parts 2-3 of the study may be increased or decreased based on the subject\'s tolerability and on the subject\'s response to treatment.\n\nIn the phase 1b dose optimization of the study (Part 4), further dose escalation of TTI-621, beyond the dose determined during phase 1a dose escalation, will be pursued in patients with relapsed and/or refractory CTCL following a 3+3 escalation design and using a revised DLT criteria to further evaluate the safety and tolerability of TTI-621 at dose levels higher than the initially recommended phase 1b Parts 2-3.\n\nSecondary objectives include further characterization of the pharmacokinetics, pharmacodynamics, and development of ADA; and to gain preliminary evidence of the anti-tumor activity of TTI-621 in subjects with a variety of hematologic malignancies and selected solid tumors. In addition, the safety of TTI-621 will be evaluated in combination with other anti-cancer agents.\n\nPfizer decided terminating this study for administrative reasons on 22Mar2022 (stopping enrollment as of 15Apr2022). The decision wasn\'t due to safety concerns or requests from regulatory authorities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'MAJOR ELIGIBILITY CRITERIA:\n\nPhase 1a Escalation\n\n• Histologically documented, measurable, advanced lymphomas, transfusion-independence\n\nPhase 1b Expansion (Part 2 and 3) • Advanced malignancy: IBCL, ABCL, cHL, AML, ALL, MDS, MPN, SCLC, PTCL and CTCL; measurable disease who have relapsed or are refractory following at least 2 prior systemic therapeutic attempts (1 prior systemic attempt for PTCL). For CTCL, extracorporeal photochemotherapy (ECP) considered a systemic therapy. Local radiation and topical agents are not systemic therapies.\n\nPhase 1b dose optimization (Part 4)\n\n• Histologically confirmed diagnosis of CTCL (both Mycosis Fungoides and Sezary Syndrome): Failed at least 2 prior systemic therapies for CTCL (Systemic therapy does not include local radiation therapy or topical agents); History of histologically documented diagnosis of CTCL stage IB to IVB\n\nInclusion Criteria (all subjects):\n\n* Advanced measurable malignancy with previously progressed on, or currently progressing on standard anticancer therapy or for whom no other approved conventional therapy exists\n* Eastern Cooperative Oncology Group (ECOG) 0-2\n* Adequate hematologic, hepatic, renal, and coagulation function; fresh or archived tumor tissue available for immunohistochemistry\n* Recovery from prior treatments and/or surgeries; no history of hemolytic anemia or bleeding diathesis.\n* AML M3 (French American British, FAB, classification) (i.e., acute promyelocytic leukemia \\[APL\\]) excluded\n\nExclusion Criteria:\n\n* Known current central nervous system disease involvement or untreated brain metastases\n* Allogeneic transplant within 30 days prior to the planned start of treatment or subjects with active graft-vs-host disease with the exception of Grade 1 skin involvement\n* History of hemolytic anemia or bleeding diathesis'}, 'identificationModule': {'nctId': 'NCT02663518', 'briefTitle': 'A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1a/1b Dose Escalation and Expansion Trial of TTI-621, a Novel Biologic Targeting CD47, in Subjects With Relapsed or Refractory Hematologic Malignancies and Selected Solid Tumors', 'orgStudyIdInfo': {'id': 'TTI-621-01'}, 'secondaryIdInfos': [{'id': 'C4961001', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 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expansion cohort with PF-07901800 (TTI-621)', 'interventionNames': ['Drug: PF-0791800 (TTI-621)']}, {'type': 'EXPERIMENTAL', 'label': 'Rituximab Combination', 'description': 'Combination therapy expansion cohort with PF-07901800 (TTI-621) plus Rituximab for CD20 positive malignancies', 'interventionNames': ['Drug: PF-07901800 (TTI-621) plus Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Nivolumab Combination', 'description': 'Combination therapy expansion cohort with PF-07901800 (TTI-621) plus Nivolumab for Hodgkin Lymphoma', 'interventionNames': ['Drug: PF-07901800 (TTI-621) plus Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cutaneous T-Cell Lymphoma (CTCL)', 'description': 'Monotherapy expansion cohort with PF-07901800 (TTI-621)', 'interventionNames': ['Drug: PF-0791800 (TTI-621)']}, {'type': 'EXPERIMENTAL', 'label': 'Peripheral T-Cell Lymphoma (PTCL)', 'description': 'Monotherapy expansion cohort with PF-07901800 (TTI-621)', 'interventionNames': ['Drug: PF-0791800 (TTI-621)']}, {'type': 'EXPERIMENTAL', 'label': 'Part 4: Cutaneous T-Cell Lymphoma (CTCL)', 'description': 'Monotherapy expansion Part 4 (Dose Optimization) cohort with PF-07901800 (TTI-621)', 'interventionNames': ['Drug: PF-0791800 (TTI-621)']}], 'interventions': [{'name': 'PF-0791800 (TTI-621)', 'type': 'DRUG', 'otherNames': ['TTI-621 (SIRPα-IgG1 Fc)'], 'description': 'Monotherapy', 'armGroupLabels': ['Acute Myeloid Leukemia', 'Aggressive B-Cell Lymphoma', 'Chronic Lymphocytic Leukemia', 'Cutaneous T-Cell Lymphoma (CTCL)', 'Hodgkin Lymphoma', 'Indolent B-Cell Lymphoma', 'Multiple Myeloma', 'Myelodysplastic Syndrome', 'Myeloproliferative Neoplasms', 'PF-07901800 (TTI-621) Escalation Phase - R/R Lymphoma', 'Part 4: Cutaneous T-Cell Lymphoma (CTCL)', 'Peripheral T-Cell Lymphoma (PTCL)', 'Small Cell Lung Cancer', 'T-Cell Lymphoma']}, {'name': 'PF-07901800 (TTI-621) plus Rituximab', 'type': 'DRUG', 'otherNames': ['TTI-621 plus Rituxan'], 'description': 'Combination therapy', 'armGroupLabels': 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Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}