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SAR444881

Phase 2

Solid Tumors | Small molecule | Oncology |Sanofi|Last Updated: May 6, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06651593Phase II Biomarker Study of SAR444881 in Combination With Cemiplimab in Solid TumorsPHASE2 RECRUITING 40Jul 2, 2025Sep 1, 2030May 6, 20261 United States
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Study Endpoints
Primary Endpoints
Safety and adverse events (AEs)
Through study completion; an average of 1 year

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment with SAR444881 and CemiplimabEXPERIMENTALSAR444881 will be given by vein over about 60 minutes on Day 1 of each cycle. Cemiplimab will be administered by vein over about 30 minutes on Day 1 of each cycle, starting with Cycle 2. During Cycle 1, you will only receive SAR444881. Starting on Day 1 of Cycle 2 and for all other cycles, you will receive both SAR444881 and cemiplimab.
Interventions
NameTypeDescription
SAR444881DRUGGiven by IV
CemiplimabDRUGGiven by Iv
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Ability to understand and willingness to sign an informed consent form (ICF) prior to initiation of the study and any study procedures. 2. Age 18 years. 3. Participants with histologically documented locally advanced or metastatic solid tumor: * Cohort 1: NSCLC * Cohor...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06651593primaryCompletionDate: changed
LOWMay 24, 2026NCT06651593studyFirstPostDate: changed