Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors
Status:
Recruiting
Trial end date:
2025-06-16
Target enrollment:
Participant gender:
Summary
Primary Objectives:
Part 1 (Dose Escalation)
- To determine the MTD/maximum administered dose (MAD) of SAR443216 administered as a
single agent in participants with HER2 expressing solid tumors and determine the RP2D in
the dose escalation part.
- To determine the maximum lead-in dose and the recommended target dose for phase 2.
- To determine the safety of SAR443216
Part 2 (Dose expansion)
-To assess preliminary clinical activity of single agent SAR4443216 at the RP2D in
participants with HER2 expressing solid tumors, with various levels of HER2 expression.
Secondary Objectives:
Part 1
-To assess preliminary clinical activity of single agent SAR443216 at the R2PD in
participants with HER2 expressing solid tumors, with various levels of HER2 expression.
Part 2
-To determine the safety of SAR443216
Part 1 and 2
- To characterize the pharmacokinetic (PK) profile of SAR443216 when administered as a
single agent
- To evaluate the immunogenicity of SAR443216