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NCT06630806RecruitingPhase 1

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

A First-in-human, Open-label, Phase 1 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

Source: ClinicalTrials.gov · Last updated 25 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
87 (estimated)
First submitted
3 Oct 2024
Start date
30 Oct 2024
Primary completion date
16 May 2031
Lead sponsor
Sanofi
NCT number
NCT06630806
EudraCT number
2024-511667-28

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 87
  • From 30 Oct 2024 to the primary completion date, 16 May 2031
  • 19 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Participants with significant concomitant illness.
    • The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Other illness

  • 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.

Other

  • -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.
  • Inadequate organ and marrow function.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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MelbourneAustraliaRecruiting
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WollongongAustraliaRecruiting
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MontrealCanadaRecruiting
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SherbrookeCanadaRecruiting
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VancouverCanadaRecruiting
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BarcelonaSpainRecruiting
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MadridSpainRecruiting
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LilleFranceRecruiting
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NantesFranceRecruiting
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HaifaIsraelRecruiting
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JerusalemIsraelRecruiting
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Tel AvivIsraelRecruiting
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RozzanoItalyRecruiting
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ToretteItalyRecruiting
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001
Coordinator of this site? Confirm its status
HackensackUnited StatesRecruiting
Mayo Clinic in Florida- Site Number : 8400003
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
Thomas Jefferson University Hospital- Site Number : 8400002
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Mayo Clinic in Arizona - Phoenix- Site Number : 8400005
Coordinator of this site? Confirm its status
PhoenixUnited StatesRecruiting
Mayo Clinic in Rochester - Minnesota- Site Number : 8400004
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.