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SAR446523

Phase 1

Plasma Cell Myeloma Refractory | Small molecule | Oncology |Sanofi|Last Updated: Mar 25, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment87
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06630806A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory MyelomaPHASE1 RECRUITING 87 — — Oct 30, 2024May 16, 2031Mar 25, 202619 United States, Australia +5
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Study Endpoints
Primary Endpoints
Incidence of Dose Limiting Toxicities (DLTs)- Dose escalation (Part A)
Cycle 1 (28 days)

The incidence of DLTs will be evaluated using NCI CTCAE version 5.0 criteria.

Overall response rate (ORR) - Dose optimization (Part B)
24 months after the Last Participant In (LPI)

ORR is defined as the proportion of participants with sCR, CR, VGPR, and PR assessed as per Investigator according to the 2016 IMWG response criteria.

Secondary Endpoints
Number of participants with treatment emergent adverse events (TEAEs), injection related reactions (IRRs), injection site reactions (ISRs), serious adverse events (SAEs), adverse event of special interests (AESIs)
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 5 years
Change from baseline in laboratory abnormalities
From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 5 years
ORR- Dose escalation (Part A)
24 months after the Last Participant In (LPI)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A (Dose escalation)EXPERIMENTALParticipants will receive SAR446523
Part B Dose-1 (Dose optimization)EXPERIMENTALParticipants will receive SAR446523 Dose-1
Part B Dose-2 (Dose optimization)EXPERIMENTALParticipants will receive SAR446523 Dose-2
Interventions
NameTypeDescription
SAR446523DRUGPharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

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 (Par...

Countries:United StatesAustraliaCanadaFranceIsraelItalySpain
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06630806Enrollment: 82 → 87
LOWMay 24, 2026NCT06630806studyFirstPostDate: changed