First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma
Status:
Recruiting
Trial end date:
2023-05-16
Target enrollment:
Participant gender:
Summary
Primary Objectives:
- Dose Escalation Part A: To determine the maximum tolerated dose (MTD) of SAR442085
administered as a single agent in patients with relapsed or refractory multiple myeloma
(RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion
Part B
- Dose Expansion Part B: To assess the antitumor activity of single agent of SAR442085 at
the RP2D in patients with RRMM
Secondary Objectives:
- To characterize the safety profile of SAR442085
- To characterize the pharmacokinetics (PK) profile of SAR442085 when administered as a
single agent
- To evaluate the potential immunogenicity of SAR442085
- To assess preliminary evidence of antitumor activity in the Dose Escalation Part A