A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma
NCT ID: NCT06630806
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
82 participants
INTERVENTIONAL
2024-10-30
2029-05-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part A (Dose escalation)
Participants will receive SAR446523
SAR446523
Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC)
Part B Dose-1 (Dose optimization)
Participants will receive SAR446523 Dose-1
SAR446523
Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC)
Part B Dose-2 (Dose optimization)
Participants will receive SAR446523 Dose-2
SAR446523
Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC)
Interventions
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SAR446523
Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic in Arizona - Phoenix- Site Number : 8400005
Phoenix, Arizona, United States
Mayo Clinic in Florida- Site Number : 8400003
Jacksonville, Florida, United States
Mayo Clinic in Rochester - Minnesota- Site Number : 8400004
Rochester, Minnesota, United States
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001
Hackensack, New Jersey, United States
Thomas Jefferson University Hospital- Site Number : 8400002
Philadelphia, Pennsylvania, United States
Investigational Site Number : 0360001
Wollongong, New South Wales, Australia
Investigational Site Number : 0360002
Melbourne, Victoria, Australia
Investigational Site Number : 1240001
Montreal, Quebec, Canada
Investigational Site Number : 1240002
Sherbrooke, Quebec, Canada
Investigational Site Number : 2500002
Lille, , France
Investigational Site Number : 2500001
Nantes, , France
Investigational Site Number : 3760001
Tel Aviv, Malopolskie, Israel
Investigational Site Number : 3760004
Haifa, , Israel
Investigational Site Number : 3760002
Jerusalem, , Israel
Investigational Site Number : 3800002
Torette, Ancona, Italy
Investigational Site Number : 3800001
Rozzano, Milano, Italy
Investigational Site Number : 7240002
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240001
Madrid, , Spain
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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TED18162 Plain Language Results Summary
Other Identifiers
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U1111-1301-4016
Identifier Type: OTHER
Identifier Source: secondary_id
2024-511667-28
Identifier Type: REGISTRY
Identifier Source: secondary_id
TED18162
Identifier Type: -
Identifier Source: org_study_id
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