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BMS-986360

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jun 13, 2025

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 Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05625412A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid TumorsPHASE1 COMPLETED 70Dec 9, 2022May 12, 2025Jun 13, 202535 United States, Argentina +7
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Study Endpoints
Primary Endpoints
Number of participants with Adverse Events (AEs)
Up to approximately 2 years
Number of participants with Serious Adverse Events (SAEs)
Up to approximately 2 years
Number of participants with Dose-Limiting Toxicities (DLTs)
Up to approximately 2 years
Number of participants with AEs leading to discontinuation
Up to approximately 2 years
Number of deaths
Up to approximately 2 years
Secondary Endpoints
Maximum observed plasma concentration (Cmax)
Up to approximately 2 years
Time of maximum observed plasma concentration (Tmax)
Up to approximately 2 years
Area under the plasma concentration-time curve (AUC)
Up to approximately 2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-986360EXPERIMENTAL -
BMS-986360 + DocetaxelEXPERIMENTAL -
BMS-986360 + NivolumabEXPERIMENTAL -
BMS-986360 + CapecitabineEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986360DRUGSpecified dose on specified days
DocetaxelDRUGSpecified dose on specified days
NivolumabDRUGSpecified dose on specified days
CapecitabineDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Participants in Part 1 must have histologic or cytologic confirmation of non-small cell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamous cell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renal cell carcinoma (RCC), micros...

Countries:United StatesArgentinaAustraliaCanadaChileFranceItalyMexicoSpain
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