A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2027-06-11

Summary

This is a Phase 1/2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy for participants aged at least 18 years with advanced unresectable or metastatic malignancies.

The study will include 2 parts:

A dose escalation Part 1: for finding the recommended dose(s) of SAR445877 in a monotherapy given every 2 weeks (Q2W) or weekly (QW).

A multicohort dose expansion Part 2: for the assessment of safety and preliminary efficacy of SAR445877 in monotherapy (2 dose levels will be tested in at least 1 indication as applicable).

Approximately 240 participants will be enrolled to the study intervention:

For Part 1: approximately 75 participants, For Part 2: up to 30 participants will be enrolled in each cohort per dose level for a total of approximately 165.

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: Sanofi