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BMS-986504

Phase 2

Solid Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: May 29, 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 Enrollment260
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07492680A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)PHASE2 NOT YET_RECRUITING 260Jul 17, 2026May 20, 2032May 29, 202658 United States, Belgium +11
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Study Endpoints
Primary Endpoints
Part 1: Number of participants who achieve Objective Response (OR)
Up to approximately 2 years

OR is defined as confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Response Assessment in Neuro-Oncology (RANO) v2 or Modified RECIST v1.1

Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria
Up to approximately 2 years
Part 2: Number of participants with adverse events (AE)
Up to approximately 2 years
Part 2: Number of participants with Serious AEs (SAEs)
Up to approximately 2 years
Part 2: Number of participants with treatment related AEs
Up to approximately 2 years
Part 2: Number of participants with treatment related SAEs
Up to approximately 2 years
Part 2: Number of participants with AEs leading to study treatment discontinuation
Up to approximately 2 years
Part 2: Number of participants with AEs leading to death
Up to approximately 2 years
Part 2: Number of participants with laboratory abnormalities
Up to approximately 2 years
Secondary Endpoints
Part 1 and 2: Time to objective response (TTOR)
Up to approximately 2 years
Part 1 and 2: Duration of response (DOR)
Up to approximately 2 years
Part 1 and 2: Number of participants who achieve disease control (DC)
Up to approximately 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1aEXPERIMENTALBMS-986504
Part 1bEXPERIMENTALBMS-986504
Part 2: Cohort 1EXPERIMENTALBMS-986504 + Pumitamig + Chemotherapy
Part 2: Cohort 2aEXPERIMENTALBMS-986504 + Daraxonrasib
Part 2: Cohort 2bEXPERIMENTALBMS-986504 + Daraxonrasib
Part 2: Cohort 2cEXPERIMENTALBMS-986504 + Daraxonrasib + Chemotherapy
Part 2: Cohort 3EXPERIMENTALBMS-986504 + Nivolumab + Relatlimab FDC
Part 2: Cohort 4EXPERIMENTALBMS-986504 + Temozolomide + Radiotherapy
Interventions
NameTypeDescription
BMS-986504DRUGSpecified dose on specified days
DaraxonrasibDRUGSpecified dose on specified days
Nivolumab + Relatlimab FDCDRUGSpecified dose on specified days
TemozolomideDRUGSpecified dose on specified days
PumitamigDRUGSpecified dose on specified days
PemetrexedDRUGSpecified dose on specified days
CarboplatinDRUGSpecified dose on specified days
Nab-paclitaxelDRUGSpecified dose on specified days
GemcitabineDRUGSpecified dose on specified days
PaclitaxelDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites58

Inclusion Criteria: * Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue. * Depending on the cohort enrolled, participants must have received standard therapies appropriate ...

Countries:United StatesBelgiumCanadaChinaFranceGermanyHong KongIrelandItalyJapanNorwaySouth KoreaSpain
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07492680lastUpdatePostDate: changed
LOWMay 29, 2026NCT07492680lastUpdatePostDate: changed
LOWMay 29, 2026NCT07492680lastUpdatePostDate: changed
LOWMay 26, 2026NCT07492680primaryCompletionDate: changed
LOWMay 24, 2026NCT07492680studyFirstPostDate: changed