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

This is a first-in-human study of SAR446523 conducted in patients with RRMM. The study consists of two parts: Dose escalation (Part A): In this part, up to several dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose optimization part. Dose optimization (Part B): In this part, participants will be randomly assigned in a 1:1 ratio using interactive response technology (IRT) to either one of the chosen dose regimens of SAR446523 (deter

Trial Details

NCT ID
NCT06630806
Phase
PHASE1
Sponsor
Sanofi
Status
RECRUITING
Cancer Type
Relapsed/Refractory Multiple Myeloma
Interventions
  • SAR446523
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Rochester, Minnesota, United States|44.02163,-92.4699
  • Hackensack, New Jersey, United States|40.88593,-74.04347
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility Criteria

  • Participants with a documented diagnosis of multiple myeloma (MM) with measurable disease.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in cl…
  • Dose escalation (Part A)
  • Participants must have received at least 3 prior lines of antimyeloma therapy, and must be either relapsed or refractory to the above therapies, or…

For full eligibility, visit ClinicalTrials.gov.

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