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BMS-986365

Phase 3

Metastatic Castration-resistant Prostate Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jul 22, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment960
FDA Designations
No designations recorded
Trial Stopped -NCT07242781: Business objectives have changed
Clinical trial landscape

BMS-986365 · 4 trials · 3 indications

Phase 3 1Phase 1 3
NCT06764485A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate CancerMetastatic Castration-resistant Prostate Cancer
RECRUITING960 Analytics
PHASE3RECRUITING
A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
NCT06764485960
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Study Endpoints
Primary Endpoints
Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteria
Up to 4 years
Part A: Maximum Observed Plasma Concentration (Cmax) of BMS-986365
Up to approximately Day 32
Part A: Cmax of BMS-986365 Without Itraconazole
Up to approximately Day 32
Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986365 With Itraconazole
Up to approximately Day 32
Part A: AUC(0-T) of BMS-986365 Without Itraconazole
Up to approximately Day 32
Part A: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986365
Up to approximately Day 32
Part A: AUC(INF) of BMS-986365 Without Itraconazole
Up to approximately Day 32
Part B: Cmax of BMS-986365 With Rifampin
Up to approximately Day 37
Part B: Cmax of BMS-986365 Without Rifampin
Up to approximately Day 37
Part B: AUC(INF) of BMS-986365 With Rifampin
Up to approximately Day 37
Part B: AUC(INF) of BMS-986365 Without Rifampin
Up to approximately Day 37
Part B: AUC(0-T) of BMS-986365 With Rifampin
Up to approximately Day 37
Part B: AUC(0-T) of BMS-986365 Without Rifampin
Up to approximately Day 37
Maximum observed concentration (Cmax)
Up to Day 60

Part A and B

Time of maximum observed concentration (Tmax)
Up to Day 60

Part A and B

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Up to Day 60

Part A and B

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF))
Up to Day 60

Part A and B

Apparent terminal plasma half-life (T-HALF)
Up to Day 60

Part A and B

Total body clearance (CLT)
Up to Day 15

Part A

Apparent total body clearance (CLT/F)
Up to Day 60

Part A and B

Mean residence time (MRT)
Up to Day 15

Part A

Apparent volume of distribution (Vz)
Up to Day 15

Part A

Apparent volume of distribution (Vz/F)
Up to Day 60

Part A and B

Absolute bioavailability (F)
Up to Day 15

Part A

Maximum observed plasma concentration (Cmax)
Up to Day 75
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Up to Day 75
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Up to Day 75
Secondary Endpoints
Overall Survival (OS)
Up to 4 years
Recommended dose of BMS-986365 for Part 2
Up to approximately 1.5 years
Progression-free survival (PFS)
Up to 4 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Dose 1EXPERIMENTAL -
Part 1: Dose 2EXPERIMENTAL -
Part 1: Comparator 1ACTIVE_COMPARATOREnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Part 1: Comparator 2ACTIVE_COMPARATOR -
Part 2: Dose SelectedEXPERIMENTAL -
Part 2: Comparator 1ACTIVE_COMPARATOREnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Part 2: Comparator 2ACTIVE_COMPARATOR -
Part A (Safety Lead-in Group)EXPERIMENTAL -
Part A, Period 1EXPERIMENTAL -
Part A, Period 2EXPERIMENTAL -
Part B, Period 1EXPERIMENTAL -
Part B, Period 2EXPERIMENTAL -
Part AEXPERIMENTAL -
Part B - Arm 1EXPERIMENTAL -
Part B - Arm 2EXPERIMENTAL -
Part 1: Cohort 1 BMS-986365 Dose 1EXPERIMENTAL -
Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1EXPERIMENTAL -
Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2EXPERIMENTAL -
Part 1: Cohort 3 BMS-986365 Dose 4EXPERIMENTAL -
Part 1: Cohort 6 BMS-986365 Dose 5EXPERIMENTAL -
Part 1: Cohort 7 BMS-986365 Dose 6EXPERIMENTAL -
Part 1: Cohort 8 BMS-986365 Dose 7EXPERIMENTAL -
Part 1: Cohort 9 BMS-986365 Dose 8EXPERIMENTAL -
Part 2: Cohort 4 BMS-986365 Dose 9 FastedEXPERIMENTAL -
Part 2: Cohort 4 BMS-986365 Dose 10 FedEXPERIMENTAL -
Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986365DRUGSpecified dose on specified days
EnzalutamideDRUGSpecified dose on specified days
AbirateroneDRUGSpecified dose on specified days
DocetaxelDRUGSpecified dose on specified days
Predinsone/PrednisoloneDRUGSpecified dose on specified days
ItraconazoleDRUGSpecified dose on specified days
RifampinDRUGSpecified dose on specified days
[14C] BMS-986365DRUGSpecified dose on specified days.
[14C] BMS-986409 + BMS-986410DRUGSpecified dose on specified days
[14C] BMS-986410 + BMS-986409DRUGSpecified dose on specified days
RabeprazoleDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites281

Inclusion Criteria * Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features. * Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft ...

Countries:United StatesArgentinaAustraliaAustriaBrazilCanadaChileChinaCzechiaDenmarkFranceGermanyIndiaIrelandItalyJapanPolandPuerto RicoRomaniaSlovakiaSouth KoreaSpainSwedenTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWJul 22, 2026NCT06764485lastUpdatePostDate: changed
LOWJul 22, 2026NCT06764485lastUpdatePostDate: changed
CRITICALJul 20, 2026NCT07242781Status: RECRUITING → TERMINATED
CRITICALJul 20, 2026NCT07242781Status: RECRUITING → TERMINATED
LOWJun 26, 2026NCT06764485lastUpdatePostDate: changed
LOWJun 26, 2026NCT06764485lastUpdatePostDate: changed
LOWMay 26, 2026NCT07242781primaryCompletionDate: changed
LOWMay 26, 2026NCT06764485primaryCompletionDate: changed
LOWMay 24, 2026NCT07242781studyFirstPostDate: changed
LOWMay 24, 2026NCT06764485studyFirstPostDate: changed