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
- Diseases
- Multiple myeloma
- 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
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Wollongong | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Sherbrooke | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| - Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| - Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| - Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| - Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Torette | Italy | Recruiting |
| Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001 Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| Mayo Clinic in Florida- Site Number : 8400003 Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Thomas Jefferson University Hospital- Site Number : 8400002 Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Mayo Clinic in Arizona - Phoenix- Site Number : 8400005 Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Mayo Clinic in Rochester - Minnesota- Site Number : 8400004 Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.