Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-28 @ 4:04 AM
Study NCT ID:
NCT03783403
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2018-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers
Sponsor:
Organization:
Raw JSON
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Discovery and Preclinical Activity of BMS-986351, an Antibody to SIRPalpha That Enhances Macrophage-mediated Tumor Phagocytosis When Combined with Opsonizing Antibodies. Cancer Res Commun. 2024 Feb 22;4(2):505-515. doi: 10.1158/2767-9764.CRC-23-0634.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in participants with advanced solid and hematologic cancers.', 'detailedDescription': 'This is a test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Progressed on standard anticancer therapy or for whom no other approved conventional therapy exists and have histological or cytological confirmation of advanced unresectable solid tumors, advanced unresectable colorectal cancer, or squamous cell carcinoma of the head and neck, or CD20-positive non-Hodgkin's lymphoma, or diffuse large B cell lymphoma, or follicular lymphoma\n* Solid tumors must have at least one site of measurable disease as determined by RECIST v1.1\n* Eastern cooperative oncology group performance status of 0 or 1\n\nExclusion Criteria:\n\n* High-grade lymphomas (Burkitt's or lymphoblastic)\n* Has cancer with symptomatic central nervous system (CNS) involvement\n* History of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months\n\nOther protocol-defined inclusion/exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT03783403', 'briefTitle': 'A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers', 'nctIdAliases': ['NCT03816254'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 1, Open-label, Dose Finding Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers', 'orgStudyIdInfo': {'id': 'CC-95251-ST-001'}, 'secondaryIdInfos': [{'id': 'U1111-1224-8251', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CC-95251', 'interventionNames': ['Drug: CC-95251']}, {'type': 'EXPERIMENTAL', 'label': 'CC-95251 in combination with rituximab', 'interventionNames': ['Drug: CC-95251', 'Drug: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'CC-95251 in combination with cetuximab', 'interventionNames': ['Drug: CC-95251', 'Drug: Cetuximab']}], 'interventions': [{'name': 'CC-95251', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['CC-95251', 'CC-95251 in combination with cetuximab', 'CC-95251 in combination with rituximab']}, {'name': 'Rituximab', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['CC-95251 in combination with rituximab']}, {'name': 'Cetuximab', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['CC-95251 in combination with cetuximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution - 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