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BMS-986517

Phase 1

Solid Tumours | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: May 15, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment315
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07160725A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid TumorsPHASE1 RECRUITING 315 — — Oct 15, 2025Aug 1, 2028May 15, 202619 United States, Denmark +2
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Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events (AE)
Up to approximately 2 years
Number of Participants with Serious Adverse Events (SAE)
Up to approximately 2 years
Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria
Up to Day 21

For part 1 only

Number of Participants with AEs Leading to Discontinuation
Up to approximately 2 years
Number of Participants with AEs Leading to Deaths
Up to approximately 2 years
Secondary Endpoints
Objective Response Rate (ORR) Assessed by RECIST v1.1 per investigator assessment
Up to approximately 3 years
Duration of Response (DOR) Assessed by RECIST v1.1 per investigator assessment
Up to approximately 3 years
Maximum Plasma Concentration (Cmax)
Up to approximately 2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1EXPERIMENTAL -
Part 2: Cohort AEXPERIMENTAL -
Part 2: Cohort BEXPERIMENTAL -
Part 2: Cohort CEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986517DRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Participants must have an ECOG performance status of 0 to 1. * Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator). * Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastati...

Countries:United StatesDenmarkJapanSpain
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07160725primaryCompletionDate: changed
LOWMay 24, 2026NCT07160725studyFirstPostDate: changed