A First-in-human, Open-label, Phase I Study to Evaluate the Safety, Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of Subcutaneous SAR446523, an Anti-GPRC5D ADCC-enhanced Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma

Study Identifier:
TED18162
CT.gov Identifier:
NCT06630806
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
2024-511667-28-00
Study Contact Information:
N/A
Recruiting

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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.

To evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of SAR446523 in adults with RRMM

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Plasma Cell Disorders
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part A (Dose escalation)
    • Read More
  • Drug: Experimental: Part B Dose-1 (Dose optimization)
  • Drug: Experimental: Part B Dose-2 (Dose optimization)
  • Drug: Intervention/Treatment
  • Drug: SAR446523 will be administered subcutaneously at 6 dose levels, QW for Cycle 1 and Q2W for subsequent cycles with a cycle duration of 28 days.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion 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 clinical studies.
    • 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 are intolerant to them.
    • 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 is allowed.
    • Dose optimization (Part B)
    • Participants must have received at least 3 prior lines of antimyeloma therapy and be either relapsed or refractory to immunomodulator (IMiD), proteasome inhibitor (PI), anti CD38 monoclonal antibody (mAb), and anti BCMA targeting agent or are intolerant to them.
    • Note: In Part B, prior exposure to antiGPRC5D therapy is not allowed.
    • participants (N ~82) must have received ≥3 prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and must be either relapsed and/or refractory to these therapies
    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, active polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, active plasma cell leukemia. Participants with central nervous system involvement or with clinical signs of meningeal involvement of multiple myeloma.
    • Systemic antimyeloma treatment within 14 days before the first study treatment administration.
    • Prior treatment with natural killer (NK)-cell engaging therapy (such as monoclonal antibody with antibody-dependent cellular cytotoxicity as primary mechanism of action) 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Daniel Morillo Giles
    Status
    Recruiting
    Condition(s) Treated at Site
    Plasma Cell Disorders