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

Last updated: April 22, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Myeloma

Cancer

Leukemia

Treatment

SAR446523

Clinical Study ID

NCT06630806
TED18162
U1111-1301-4016
2024-511667-28
2024-511667-28-00
  • Ages > 18
  • All Genders

Study Summary

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 6 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 (determined from data coming from Part A), to determine the optimal dose as the recommended phase 2 dose (RP2D) of SAR446523.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with a documented diagnosis of multiple myeloma (MM) with measurabledisease.

  • Contraceptive use by men and women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.

Dose escalation (Part A)

  • Participants must have received at least 3 prior lines of antimyeloma therapy, andmust be either relapsed or refractory to the above therapies, or are intolerant tothem.

  • Note: In Part A, prior exposure to anti g-protein-coupled receptor, class c, group 5, member d (GPRC5D) therapy and anti B-cell maturation antigen (BCMA) therapy isallowed.

Dose optimization (Part B)

  • Participants must have received at least 3 prior lines of antimyeloma therapy and beeither relapsed or refractory to immunomodulator (IMiD), proteasome inhibitor (PI),anti CD38 monoclonal antibody (mAb), and anti BCMA targeting agent or are intolerantto them.

  • Note: In Part B, prior exposure to antiGPRC5D therapy is not allowed.

Exclusion

Exclusion Criteria:

-Participants are excluded from the study if any of the following criteria apply: Eastern cooperative oncology group performance status (ECOG PS) of 2 or greater.

  • Primary systemic and localized amyloid light chain (AL) amyloidosis, activepolyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, active plasma cell leukemia. Participants with central nervoussystem involvement or with clinical signs of meningeal involvement of multiplemyeloma.

  • Systemic antimyeloma treatment within 14 days before the first study treatmentadministration.

  • Prior treatment with natural killer (NK)-cell engaging therapy (such as monoclonalantibody with antibody-dependent cellular cytotoxicity as primary mechanism ofaction) within 90 days of the first study treatment administration.

  • Inadequate organ and marrow function.

  • Participants with significant concomitant illness.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Study Design

Total Participants: 82
Treatment Group(s): 1
Primary Treatment: SAR446523
Phase: 1
Study Start date:
October 30, 2024
Estimated Completion Date:
May 14, 2029

Study Description

The study will be considered ongoing until the last participant last visit has occurred. Participants will be allowed to continue therapy until disease progression, unacceptable AEs, participant or Investigator's request to discontinue treatment.

Connect with a study center

  • Investigational Site Number : 0360001

    Wollongong, New South Wales 2500
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360002

    Melbourne, Victoria 3065
    Australia

    Active - Recruiting

  • Investigational Site Number : 1240001

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240002

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

  • Investigational Site Number : 3760002

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Investigational Site Number : 3760001

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Investigational Site Number : 3800002

    Torette, Ancona 60020
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800001

    Rozzano, Milano 20089
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800001

    Rozzano (MI), 20089
    Italy

    Site Not Available

  • Thomas Jefferson University Hospital- Site Number : 8400002

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

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