Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-30 @ 3:12 AM
Study NCT ID:
NCT02890368
Status:
TERMINATED
Last Update Posted:
2023-04-05
First Post:
2016-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009182', 'term': 'Mycosis Fungoides'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D015266', 'term': 'Carcinoma, Merkel Cell'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626237', 'term': 'TTI-621'}, {'id': 'C000629782', 'term': 'talimogene laherparepvec'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2016-08-31', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimal TTI-621 delivery regimen', 'timeFrame': '10 months', 'description': 'Defining the optimal TTI-621 delivery regimen in subjects with advanced percutaneously-accessible cancer'}], 'secondaryOutcomes': [{'measure': 'Frequency and severity of adverse events', 'timeFrame': '15 months', 'description': 'Safety of TTI-621 when given to subjects with relapsed and refractory percutaneously-accessible solid tumors and Mycosis Fungoides alone and in combination with other anti-cancer drugs or radiation'}, {'measure': 'Preliminary evidence of anti-tumor activity of TTI-621', 'timeFrame': '15 months', 'description': 'Preliminary evidence of anti-tumor activity of TTI-621 when given to subjects with relapsed and refractory percutaneously-accessible solid tumors and Mycosis Fungoides alone and in combination with other anti-cancer drugs or radiation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CD47', 'SIRPa', 'Immunotherapy', 'Checkpoint inhibitor'], 'conditions': ['Solid Tumors', 'Mycosis Fungoides', 'Melanoma', 'Merkel-cell Carcinoma', 'Squamous Cell Carcinoma', 'Breast Carcinoma', 'Human Papillomavirus-Related Malignant Neoplasm', 'Soft Tissue Sarcoma']}, 'referencesModule': {'references': [{'pmid': '34627593', 'type': 'DERIVED', 'citation': 'Querfeld C, Thompson JA, Taylor MH, DeSimone JA, Zain JM, Shustov AR, Johns C, McCann S, Lin GHY, Petrova PS, Uger RA, Molloy N, Shou Y, Akilov OE. Intralesional TTI-621, a novel biologic targeting the innate immune checkpoint CD47, in patients with relapsed or refractory mycosis fungoides or Sezary syndrome: a multicentre, phase 1 study. Lancet Haematol. 2021 Nov;8(11):e808-e817. doi: 10.1016/S2352-3026(21)00271-4. Epub 2021 Oct 7.'}, {'pmid': '34519839', 'type': 'DERIVED', 'citation': 'Kruglov O, Johnson LDS, Minic A, Jordan K, Uger RA, Wong M, Sievers EL, Shou Y, Akilov OE. The pivotal role of cytotoxic NK cells in mediating the therapeutic effect of anti-CD47 therapy in mycosis fungoides. Cancer Immunol Immunother. 2022 Apr;71(4):919-932. doi: 10.1007/s00262-021-03051-x. Epub 2021 Sep 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label, phase 1 study conducted to test intratumoral injections of TTI-621 in subjects that have relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides.\n\nThe study will be performed in two different parts. Part 1 is the Dose Escalation phase and Part 2 is the Dose Expansion phase.\n\nThe purpose of this study is to characterize the safety profile of TTI-621 and to determine the optimal dose and delivery schedule of TTI-621. In addition, the safety and antitumor activity of TTI-621 will be evaluated in combination with other anti-cancer agents or radiation.', 'detailedDescription': 'This is a multicenter, open-label, phase 1 study conducted to test intratumoral injections of TTI-621 in patients that have relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides.\n\nTTI-621 (SIRPα-IgG1 Fc) 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" (antiphagocytic) signal to macrophages.\n\nThe study will be performed in two different parts: Dose Escalation and Dose Expansion.\n\nDuring the escalation part of the study, TTI-621 was studied at 3 different dose levels and at different dosing frequencies to characterize safety, tolerability, pharmacokinetics, and to determine the maximum tolerated dose (MTD).\n\nDuring the expansion part of the study, TTI-621 will be studied in an expanded group of patients at the maximum feasible dosing regimen determined in the escalation phase. After completion of their initial assigned therapy, subjects may receive continuation with TTI-621. The expansion phase will further define safety and characterize efficacy of TTI-621 alone and in combination with other anti-cancer therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically documented, injectable cancer lesion (limited to solid tumors and mycosis fungoides)\n* Adequate renal function\n* Adequate coagulation function\n* Adequate hepatic function\n* Disease that has progressed on standard therapy or for whom there is no other therapy option available\n\nExclusion Criteria:\n\n* Central nervous system involvement\n* Significant cardiovascular disease\n* Active autoimmune disease\n* Active hepatitis B or C or a history of HIV infection\n* Uncontrolled infection\n* History of hemolytic anemia or bleeding diathesis'}, 'identificationModule': {'nctId': 'NCT02890368', 'briefTitle': 'Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1 Dose Escalation Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Percutaneously-Accessible Solid Tumors and Mycosis Fungoides', 'orgStudyIdInfo': {'id': 'TTI-621-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TTI-621 Monotherapy Escalation', 'description': 'TTI-621 Escalation phase of single or multiple doses of TTI-621 delivered by intratumoral injections (various dose cohorts).', 'interventionNames': ['Drug: TTI-621 Monotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'TTI-621 Monotherapy (Single Lesion)', 'description': 'TTI-621 Single Lesion Injection Expansion Cohort', 'interventionNames': ['Drug: TTI-621 Monotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'TTI-621 Monotherapy (Multiple Lesions)', 'description': 'TTI-621 Multiple Lesion Injections Expansion Cohort', 'interventionNames': ['Drug: TTI-621 Monotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'TTI-621 + PD-1/PD-L1 Inhibitor', 'description': 'Combination Therapy Expansion Cohort of TTI-621 plus PD-1/PD-L1 Inhibitor', 'interventionNames': ['Drug: TTI-621 + PD-1/PD-L1 Inhibitor']}, {'type': 'EXPERIMENTAL', 'label': 'TTI-621 + Pegylated Interferon-α2a', 'description': 'Combination Therapy Expansion Cohort of TTI-621 plus Pegylated Interferon-α2a', 'interventionNames': ['Drug: TTI-621 + pegylated interferon-α2a']}, {'type': 'EXPERIMENTAL', 'label': 'TTI-621 + T-Vec', 'description': 'Combination Therapy Expansion Cohort of TTI-621 plus T-Vec', 'interventionNames': ['Other: TTI-621 + T-Vec']}, {'type': 'EXPERIMENTAL', 'label': 'TTI-621 + Radiation', 'description': 'Combination Therapy Expansion Cohort of TTI-621 plus Radiation Therapy', 'interventionNames': ['Other: TTI-621 + radiation']}], 'interventions': [{'name': 'TTI-621 Monotherapy', 'type': 'DRUG', 'otherNames': ['SIRPα-IgG1 Fc'], 'description': 'TTI-621 (SIRPα-IgG1 Fc) 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" (antiphagocytic) signal to macrophages.', 'armGroupLabels': ['TTI-621 Monotherapy (Multiple Lesions)', 'TTI-621 Monotherapy (Single Lesion)', 'TTI-621 Monotherapy Escalation']}, {'name': 'TTI-621 + PD-1/PD-L1 Inhibitor', 'type': 'DRUG', 'otherNames': ['SIRPα-IgG1 Fc + PD-1/PD-L1 Inhibitor'], 'description': 'TTI-621 will be given in combination with one of the following programmed death-1 (PD-1) or programmed death-ligand-1 (PD-L1) inhibitors: nivolumab, pembrolizumab, durvalumab, avelumab, or atezolizumab administered on Day 1. Subjects in this cohort must have a cancer diagnosis for which a PD-1/PD-L1 inhibitor is approved by the FDA or listed in the National Comprehensive Cancer Network (NCCN) Guidelines.', 'armGroupLabels': ['TTI-621 + PD-1/PD-L1 Inhibitor']}, {'name': 'TTI-621 + pegylated interferon-α2a', 'type': 'DRUG', 'otherNames': ['SIRPα-IgG1 Fc + pegylated interferon-α2a'], 'description': 'TTI-621 will be given in combination with pegylated interferon-α2a. Subjects in this cohort must have a cancer diagnosis for which pegylated interferon-α2a is approved by the FDA or listed in the National Comprehensive Cancer Network (NCCN) Guidelines.', 'armGroupLabels': ['TTI-621 + Pegylated Interferon-α2a']}, {'name': 'TTI-621 + T-Vec', 'type': 'OTHER', 'otherNames': ['SIRPα-IgG1 Fc + talimogene laherparepvec'], 'description': 'TTI-621 will be given in combination with talimogene laherparepvec (T-Vec). Subjects in this cohort must have unresectable melanoma.', 'armGroupLabels': ['TTI-621 + T-Vec']}, {'name': 'TTI-621 + radiation', 'type': 'OTHER', 'otherNames': ['SIRPα-IgG1 Fc + radiation'], 'description': 'TTI-621 will be given following radiation to the target plasmacytoma. Subjects in this cohort must have relapsed multiple myeloma with bony or soft tissue plasmacytoma(s).', 'armGroupLabels': ['TTI-621 + Radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Laura and Isaac Perlmutter Cancer Center at NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15237', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Schar Cancer Institute', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington - Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}