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BMS-986500

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Apr 21, 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 Enrollment234
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06997029A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid TumorsPHASE1 RECRUITING 234Aug 1, 2025Dec 14, 2028Apr 21, 202621 United States, Denmark +1
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Study Endpoints
Primary Endpoints
Number of Participants With Dose Limiting Toxicities (DLTs)
Up to Day 28 From Last Dose
Number of Participants With Adverse Events (AEs)
Up to Day 28 From Last Dose
Number of Participants With Serious Adverse Events (SAEs)
Up to Day 28 From Last Dose
Number of Participants With AEs Leading to Discontinuation
Up to Day 28 From Last Dose
Number of Participants With TEAEs Leading to Death
Up to Day 28 From Last Dose
Secondary Endpoints
Maximum Observed Serum Concentration (Cmax) of BMS-986500
Up to Approximately 2 Years
Time of Maximum Observed Serum Concentration (Tmax) of BMS-986500
Up to Approximately 2 Years
Area Under the Concentration-time Curve Within a Dosing Interval (AUC(TAU)) of BMS-986500
Up to Approximately 2 Years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1A Monotherapy Dose EscalationEXPERIMENTAL -
Part 1B Combination Dose EscalationEXPERIMENTAL -
Part 1C Monotherapy Pharmacodynamic (PD) Sub-studyEXPERIMENTAL -
Part 2A Monotherapy Dose ExpansionEXPERIMENTAL -
Part 2B Combination Dose ExpansionEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986500DRUGSpecified dose of specified days
PalbociclibDRUGSpecified dose on specified days
FulvestrantDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Participants must be ≥ 18 years of age. * Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy. * Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST...

Countries:United StatesDenmarkJapan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06997029primaryCompletionDate: changed
LOWMay 24, 2026NCT06997029studyFirstPostDate: changed