*CC-95251-ST-001 Alone and in Combo in Subjects with AS and HC
Research type
Research Study
Full 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
IRAS ID
1004948
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2020-000240-55
Clinicaltrials.gov Identifier
Research summary
This is a multicentre, phase 1 study of the investigational drug CC-95251 alone and in combination with Cetuximab or Rituximab in Subjects with Advanced Solid and Hematologic Cancers. CC-95251 is given as an intravenous infusion and may require hospitalisation for at least 24 hours. 230 patients will take part in this study, 6 in UK. Patients and Doctors will know what treatment the patient will be receiving. The study has 3 parts (A-C): dose escalation (Part A) and expansion (Parts B & C). Part B will further evaluate the safety and efficacy of CC-95251 administered at or below the Stage 2 maximum tolerated dose (MTD) in combination with cetuximab in selected expansion cohorts of up to approximately 20 evaluable subjects each, in order to determine the recommended Phase 2 dose. Part B expansion cohorts may include subjects with advanced CRC, SCCHN, and/or other advanced solid cancers. Part C will further evaluate the safety and efficacy of CC-95251 administered at or below the Stage 3 MTD in combination with rituximab in selected expansion cohorts of up to approximately 20 (FL) or 30 (DLBCL) evaluable subjects each, Part C expansion cohorts may include DLBCL. All treatments will be administered in 28-day cycles until clinically significant disease progression, unacceptable toxicity, or subject/Investigator decision to withdraw. Parts A, B and C will consist of 3 periods: Screening, Treatment, and Follow-up. During the study, patients will have the following procedures: physical exams, heart scans (MUGA/ECHO), ECG, vital signs (BP, HR and temp), blood & urine sampling and pregnancy testing. Patients will receive study drug for max. 2 years, until they withdraw their consent, no longer tolerate the study drug, or their disease worsens. Patients will have follow-up until about 56 days from last dose. Long-term follow-up will be every 12 weeks for the 1st year Part B or the 2nd year Part C then every 12 weeks (in clinic/by phone) for up to 2 years, death or trial end.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0293
Date of REC Opinion
4 Apr 2022
REC opinion
Further Information Favourable Opinion