Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-03-06 @ 4:56 PM
Study NCT ID:
NCT03013218
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2016-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712178', 'term': 'ALX148'}, {'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D000096662', 'term': 'Ramucirumab'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'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': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2016-12-15', 'studyFirstSubmitQcDate': '2017-01-05', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicities (Number of participants with a DLT)', 'timeFrame': 'Up to 28 days', 'description': 'Number of participants with a DLT'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neoplasms', 'CD47', 'SIRPĪ±', 'ALX148', 'Evorpacept'], 'conditions': ['Metastatic Cancer', 'Solid Tumor', 'Advanced Cancer', 'NonHodgkin Lymphoma']}, 'referencesModule': {'references': [{'pmid': '40207726', 'type': 'DERIVED', 'citation': 'Kim TM, Lakhani NJ, Soumerai J, Kamdar M, Gainor JF, Messersmith W, Fanning P, Guan S, Jin F, Forgie A, Wan HI, Pons J, Randolph SS, Kim WS. Evorpacept plus rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma: results from the phase I ASPEN-01 study. Haematologica. 2025 Sep 1;110(9):2102-2112. doi: 10.3324/haematol.2024.286208. Epub 2025 Apr 10.'}, {'pmid': '34793719', 'type': 'DERIVED', 'citation': 'Lakhani NJ, Chow LQM, Gainor JF, LoRusso P, Lee KW, Chung HC, Lee J, Bang YJ, Hodi FS, Kim WS, Santana-Davila R, Fanning P, Squifflet P, Jin F, Kuo TC, Wan HI, Pons J, Randolph SS, Messersmith WA. Evorpacept alone and in combination with pembrolizumab or trastuzumab in patients with advanced solid tumours (ASPEN-01): a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study. Lancet Oncol. 2021 Dec;22(12):1740-1751. doi: 10.1016/S1470-2045(21)00584-2. Epub 2021 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'A phase 1, dose escalation study of evorpacept (ALX148) in patients with advanced solid tumors and lymphoma', 'detailedDescription': 'This phase 1 clinical study (AT148001) is an open-label, multi-center, multiple-dose, dose-escalation, safety, PK, and PD study of evorpacept (ALX148). The phase 1 protocol will have 2 parts: a single agent dose escalation phase (Part 1) and a combination therapy phase (Part 2). Part 2 will include an initial dose escalation portion followed by a dose expansion portion. Approximately 184 adult patients are expected to be enrolled in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy; or relapsed or refractory Non-Hodgkin lymphoma for whom no standard therapy is available..\n* Adequate Bone Marrow Function.\n* Adequate Renal \\& Liver Function.\n* Adequate Performance Status\n\nExclusion Criteria:\n\n* Patients with known symptomatic CNS metastases or lepotomeningeal disease requiring steroids.\n* Previous high-dose chemotherapy requiring allogenic stem cell rescue.\n* Prior treatment with a CD47 or signal regulatory protein (SIRP) alpha targeting agent.'}, 'identificationModule': {'nctId': 'NCT03013218', 'briefTitle': 'A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALX Oncology Inc.'}, 'officialTitle': 'A Phase 1, Dose Escalation Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)', 'orgStudyIdInfo': {'id': 'AT148001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evorpacept (ALX148)', 'description': 'The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.', 'interventionNames': ['Drug: Evorpacept (ALX148)']}, {'type': 'EXPERIMENTAL', 'label': 'Evorpacept (ALX148) + Pembrolizumab', 'description': 'The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.', 'interventionNames': ['Drug: Evorpacept (ALX148)', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Evorpacept (ALX148) + Trastuzumab', 'description': 'The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.', 'interventionNames': ['Drug: Evorpacept (ALX148)', 'Drug: Trastuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Evorpacept (ALX148) + Rituximab', 'description': 'The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with rituximab infusions.', 'interventionNames': ['Drug: Evorpacept (ALX148)', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum', 'description': 'The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions.', 'interventionNames': ['Drug: Evorpacept (ALX148)', 'Drug: Pembrolizumab', 'Drug: 5-FU + Cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel', 'description': 'The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.', 'interventionNames': ['Drug: Evorpacept (ALX148)', 'Drug: Trastuzumab', 'Drug: Ramucirumab + Paclitaxel']}], 'interventions': [{'name': 'Evorpacept (ALX148)', 'type': 'DRUG', 'description': 'Evorpacept (ALX148)', 'armGroupLabels': ['Evorpacept (ALX148)', 'Evorpacept (ALX148) + Pembrolizumab', 'Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum', 'Evorpacept (ALX148) + Rituximab', 'Evorpacept (ALX148) + Trastuzumab', 'Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Keytruda', 'armGroupLabels': ['Evorpacept (ALX148) + Pembrolizumab', 'Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum']}, {'name': 'Trastuzumab', 'type': 'DRUG', 'description': 'Herceptin', 'armGroupLabels': ['Evorpacept (ALX148) + Trastuzumab', 'Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel']}, {'name': 'Rituximab', 'type': 'DRUG', 'description': 'Rituxan', 'armGroupLabels': ['Evorpacept (ALX148) + Rituximab']}, {'name': 'Ramucirumab + Paclitaxel', 'type': 'DRUG', 'description': 'Standard of care chemotherapy', 'armGroupLabels': ['Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel']}, {'name': '5-FU + Cisplatin', 'type': 'DRUG', 'description': 'Standard of care chemotherapy', 'armGroupLabels': ['Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'START-Midwest', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALX Oncology Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}