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NCT06630806PHASE1Recruiting

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

Sanofi

Start Date

10/30/2024

Completion Date

5/16/2031

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

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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. 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.

Interventions

DRUG

SAR446523

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Conditions

Plasma Cell Myeloma Refractory

Locations

Mayo Clinic in Arizona - Phoenix- Site Number : 8400005

Phoenix, Arizona 85054

United States

Mayo Clinic in Florida- Site Number : 8400003

Jacksonville, Florida 32224

United States

Mayo Clinic in Rochester - Minnesota- Site Number : 8400004

Rochester, Minnesota 55905

United States

Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001

Hackensack, New Jersey 07601

United States

Thomas Jefferson University Hospital- Site Number : 8400002

Philadelphia, Pennsylvania 19107

United States

Investigational Site Number : 0360001

Wollongong, New South Wales 2500

Australia

Investigational Site Number : 0360002

Melbourne, Victoria 3065

Australia

Investigational Site Number : 1240005

Vancouver, British Columbia V5Z 1L3

Canada

Investigational Site Number : 1240001

Montreal, Quebec H4A 3J1

Canada

Investigational Site Number : 1240002

Sherbrooke, Quebec J1H 5N4

Canada

Investigational Site Number : 2500002

Lille, 59037

France

Investigational Site Number : 2500001

Nantes, 44093

France

Investigational Site Number : 3760001

Tel Aviv, Malopolskie 6423906

Israel

Investigational Site Number : 3760004

Haifa, 3109601

Israel

Investigational Site Number : 3760002

Jerusalem, 9112001

Israel

Investigational Site Number : 3800002

Torette, Ancona 60020

Italy

Investigational Site Number : 3800001

Rozzano, Milano 20089

Italy

Investigational Site Number : 7240002

Barcelona, Barcelona [Barcelona] 08035

Spain

Investigational Site Number : 7240001

Madrid, 28040

Spain