A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers

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

Summary:

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.

Trial Description

Primary Outcome:

• Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
• Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects
• Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria

• Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)
• Time to response (TTR): Time from the first dose to the first objective tumour response observed for participants who achieved a CR or PR
• Duration of response (DOR): Time from the first objective tumour response observed for participants who achieved a CR or PR until the first date at progressive disease is objectively documented
• Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause
• Overall survival (OS): Time from the first dose to death due to any cause
• Pharmacokinetic - Maximum serum concentration of the drug (Cmax)
• Pharmacokinetic - Minimum serum concentration of the drug (Cmin)
• Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC)
• Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies

View this trial on ClinicalTrials.gov