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BMS-986488

Phase 1

Advanced Malignant Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jun 3, 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 Enrollment437
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06764771A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant TumorsPHASE1 RECRUITING 437 — — Mar 25, 2025Oct 15, 2027Jun 3, 20268 United States, Australia +1
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Study Endpoints
Primary Endpoints
Number of participants with Adverse Events (AEs)
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of participants with Serious AEs (SAEs)
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria
From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)
Number of participants with AEs leading to discontinuation
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of deaths
From time of informed consent up to 52 weeks after end of treatment visit
Secondary Endpoints
Maximum observed plasma concentration (Cmax)
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Time of maximum observed concentration (Tmax)
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1A: BMS-986488 MonotherapyEXPERIMENTAL -
Part 1B: BMS-986488 + AdagrasibEXPERIMENTAL -
Part 1C: BMS-986488 + Adagrasib + CetuximabEXPERIMENTAL -
Part 1D: BMS-986488 + NivolumabEXPERIMENTAL -
Part 2A: BMS-986488 MonotherapyEXPERIMENTAL -
Part 2B: BMS-986488 + AdagrasibEXPERIMENTAL -
Part 2C: BMS-986488 + Adagrasib + CetuximabEXPERIMENTAL -
Part 2D: BMS-986488 + NivolumabEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986488DRUGSpecified dose on specified days
AdagrasibDRUGSpecified dose on specified days
CetuximabDRUGSpecified dose on specified days
NivolumabDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Participant must be ≥ 18 years of age. * Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:. * Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC),...

Countries:United StatesAustraliaCanada
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT06764771Status: ACTIVE_NOT_RECRUITING → RECRUITING
LOWJun 4, 2026NCT06764771Status: ACTIVE_NOT_RECRUITING → RECRUITING
LOWJun 4, 2026NCT06764771Status: ACTIVE_NOT_RECRUITING → RECRUITING
LOWJun 4, 2026NCT06764771Status: ACTIVE_NOT_RECRUITING → RECRUITING
LOWJun 4, 2026NCT06764771Status: ACTIVE_NOT_RECRUITING → RECRUITING
LOWMay 26, 2026NCT06764771primaryCompletionDate: changed
LOWMay 24, 2026NCT06764771studyFirstPostDate: changed