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BMS-986523

Phase 1

Advanced Solid Malignancies | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: May 28, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment252
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07223047A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid MalignanciesPHASE1 RECRUITING 252 — — Nov 25, 2025Oct 13, 2028May 28, 20268 United States, Canada +1
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Study Endpoints
Primary Endpoints
Number of participants with adverse events (AEs)
Up to 3 years
Number of participants with serious adverse events (SAEs)
Up to 3 years
Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Up to 3 years
Number of participants with AEs leading to discontinuation
Up to 3 years
Number of deaths
Up to 3 years
Secondary Endpoints
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator.
Up to 3 years
Duration of response (DOR) per RECIST v1.1 as assessed by the investigator.
Up to 3 years
Maximum observed plasma concentration (Cmax)
Up to 3 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BEXPERIMENTAL -
Arm CEXPERIMENTAL -
Arm DEXPERIMENTAL -
Arm EEXPERIMENTAL -
Arm FEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986523DRUGSpecified dose on specified days
GemcitabineDRUGSpecified dose on specified days
Nab-PaclitaxelDRUGSpecified dose on specified days
CetuximabDRUGSpecified dose on specified days
PembrolizumabDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria * Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification). * Participants must, for Arm D, have a ...

Countries:United StatesCanadaSpain
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07223047lastUpdatePostDate: changed
LOWMay 29, 2026NCT07223047lastUpdatePostDate: changed
LOWMay 29, 2026NCT07223047lastUpdatePostDate: changed
LOWMay 26, 2026NCT07223047primaryCompletionDate: changed
LOWMay 24, 2026NCT07223047studyFirstPostDate: changed