Evaluation of SAR408701 in Patients With Advanced Solid Tumors
Status:
Active, not recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
Summary
Primary Objectives:
- To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy,
once every 2 weeks (with and without a loading dose at Cycle 1) to patients with
advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W).
- To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy,
once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle).
- To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST
1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without
a loading dose at Cycle 1.
Secondary Objectives:
- To characterize the overall safety profile of SAR408701.
- To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential
circulating derivatives.
- To identify the recommended phase 2 dose (RP2D) of SAR408701.
- To assess the potential immunogenicity of SAR408701.