Phase 1 Study of SAR446523 Given by Injection Under the Skin to Adults with Relapsed or Refractory Multiple Myeloma Evaluating Safety, Effectiveness, and Best Dose

What this Trial Is About

Researchers are evaluating SAR446523, an anti-GPRC5D ADCC-enhanced monoclonal antibody, in adults with relapsed or refractory multiple myeloma who have received multiple prior treatments. This first-in-human, open-label Phase 1 trial aims to assess the safety, antitumor activity, and pharmacokinetics of SAR446523. The study is sponsored by Sanofi and will continue until the last participants last visit, allowing therapy continuation until disease progression, unacceptable side effects, or discontinuation requests. The trial has two parts Part A involves dose escalation to find the maximum tolerated and recommended dose range at several dose levels of SAR446523 given by subcutaneous injection. Part B is a dose optimization phase where participants are randomly assigned to one of two dose regimens determined from Part A data to establish the recommended phase 2 dose. Participants receive SAR446523 subcutaneously in both parts. Participants will undergo safety evaluations, laboratory tests, and assessments for adverse events during treatment lasting up to approximately five years. Researchers will measure dose-limiting toxicities, overall response rates, and other efficacy outcomes such as progression-free survival and duration of response over 24 months after the last participant is enrolled. The study also monitors pharmacokinetics, immunogenicity, and quality of life impact throughout the treatment and follow-up period.

A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma