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

Official Title

A Phase 1, Open-Label, Dose Finding Study of CC-95251, A Monoclonal Antibody Directed Against SIRPa, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers

Summary:

Study CC-95251-ST-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Parts B and C), first-in-human clinical study of CC-95251 in subjects with advanced cancers.

Trial Description

Primary Outcome:

• Adverse Event(s)
• Non-Tolerated Dose (NTD)
• Maximum Tolerated Dose (MTD)
• Dose-Limiting Toxicity (DLT)

Secondary Outcome:

• Overall response rate (ORR)
• Time to response (TTR)
• Duration of response (DOR)
• Progression free survival (PFS)
• Overall survival (OS)
• Pharmacokinetic - Cmax
• Pharmacokinetic - Cmin
• Pharmacokinetic - AUC
• Pharmacokinetic - tmax
• Pharmacokinetic - t1/2
• Pharmacokinetic - CL
• Pharmacokinetic - Vss
• Anti-CC-95251 antibody (ADA) assessment

Study CC-95251-ST-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B & Part C), first-in-human clinical study of CC-95251 in subjects with advanced solid & hematologic cancers. The dose escalation part (Part A) of the study will be conducted in three stages. Stage 1 will evaluate the safety and tolerability of escalating doses of CC-95251, administered IV, to determine the maximum tolerated dose (MTD), non-tolerated dose (NTD), and/or recommended Phase 2 dose (RP2D) of CC-95251. Stage 2 will evaluate the safety and tolerability of escalating doses of CC-95251 in combination with weekly cetuximab, both administered IV, to determine the MTD, NTD, and/or RP2D of CC-95251 plus cetuximab. Stage 3 will evaluate the safety and tolerability of escalating doses of CC-95251 in combination with rituximab, both administered IV, to establish MTD, NTD, and/or RP2D of CC-95251 plus rituximab.

View this trial on ClinicalTrials.gov