A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers
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ClinicalTrials.gov Identifier: NCT03783403 |
Recruitment Status :
Active, not recruiting
First Posted : December 21, 2018
Last Update Posted : April 28, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neoplasms | Drug: CC-95251 Drug: Rituximab Drug: Cetuximab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 230 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | February 1, 2019 |
Estimated Primary Completion Date : | June 20, 2024 |
Estimated Study Completion Date : | August 25, 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: CC-95251 |
Drug: CC-95251
Specified dose on specified days |
Experimental: CC-95251 in combination with rituximab |
Drug: CC-95251
Specified dose on specified days Drug: Rituximab Specified dose on specified days |
Experimental: CC-95251 in combination with cetuximab |
Drug: CC-95251
Specified dose on specified days Drug: Cetuximab Specified dose on specified days |
- Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects [ Time Frame: 18 months ]
- Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects [ Time Frame: 18 months ]
- Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria [ Time Frame: 30 months ]
- Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR) [ Time Frame: 72 Months ]
- Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR [ Time Frame: 66 Months ]
- Duration of response (DOR): Time from the first objective tumor response observed for participants who achieved a CR or PR until the first date at progressive disease is objectively documented [ Time Frame: 66 Months ]
- Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause [ Time Frame: 66 Months ]
- Overall survival (OS): Time from the first dose to death due to any cause [ Time Frame: 66 Months ]
- Pharmacokinetic - Maximum serum concentration of the drug (Cmax) [ Time Frame: 36 Months ]
- Pharmacokinetic - Minimum serum concentration of the drug (Cmin) [ Time Frame: 36 Months ]
- Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC) [ Time Frame: 36 Months ]
- Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies [ Time Frame: 36 Months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Solid tumors must have at least one site of measurable disease as determined by RECIST v1.1
- Eastern cooperative oncology group performance status of 0 or 1
Exclusion Criteria:
- High-grade lymphomas (Burkitt's or lymphoblastic)
- Has cancer with symptomatic central nervous system (CNS) involvement
- 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
Other protocol-defined inclusion/exclusion criteria apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783403

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Celgene |
ClinicalTrials.gov Identifier: | NCT03783403 |
Obsolete Identifiers: | NCT03816254 |
Other Study ID Numbers: |
CC-95251-ST-001 U1111-1224-8251 ( Registry Identifier: WHO ) |
First Posted: | December 21, 2018 Key Record Dates |
Last Update Posted: | April 28, 2023 |
Last Verified: | April 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Antibody CC-95251 SIRPα Advanced Solid Cancers Advanced Hematologic Cancers |
Hematologic Neoplasms Neoplasms by Site Neoplasms Hematologic Diseases Rituximab Cetuximab |
Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |