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BMS-986460

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Aug 10, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986460 · 2 trials · 2 indications

Phase 1 2
NCT06877702A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male ParticipantsHealthy Volunteers
COMPLETED85 Analytics
NCT06067841A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate CancerMetastatic Castration-resistant Prostate Cancer
RECRUITING140 Analytics
PHASE1COMPLETED
A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants
Healthy VolunteersUnlock trial analytics
PHASE1RECRUITING
A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
Metastatic Castration-resistant Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Number of Participants With Adverse Events (AEs)
Up to approximately Day 43
Part 1: Number of Participants With Serious AEs (SAEs)
Up to approximately Day 43
Part 1: Number of Participants With Clinically Significant Physical Evaluation (PE) Findings
Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities
Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings
Up to approximately Day 21
Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986460
Up to approximately Day 21
Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986460
Up to approximately Day 21
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) of BMS-986460
Up to approximately Day 21
Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986460
Up to approximately Day 21
Part 1: Relative Bioavailability (rBA) of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on Geometric Mean Ratio (GMR) of Cmax
Up to approximately Day 21
Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(0-T)
Up to approximately Day 21
Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(INF)
Up to approximately Day 21
Part 2: Number of Participants With AEs
Up to approximately Day 29
Part 2: Number of Participants With SAEs
Up to approximately Day 29
Part 2: Number of Participants With Clinically Significant PE Findings
Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities
Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant 12-lead ECG Findings
Up to approximately Day 7
Part 2: Cmax of BMS-986460
Up to approximately Day 7
Part 2: Tmax of BMS-986460
Up to approximately Day 7
Part 2: AUC [0-T] of BMS-986460
Up to approximately Day 7
Part 2: AUC(INF) of BMS-986460
Up to approximately Day 7
Number of participants with adverse events (AEs)
Up to 112 weeks
Number of participants with serious adverse events (SAEs)
Up to 112 weeks
Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria
Up to 28 days
Number of participants with AEs leading to study intervention discontinuation
Up to 104 weeks
Number of deaths
Up to 108 weeks

Secondary Endpoints

Part 2: Pharmacokinetic (PK) Linearity of BMS-986460 Based on Cmax
Up to approximately Day 7
Part 2: PK Linearity of BMS-986460 Based on AUC(0-T)
Up to approximately Day 7
Part 2: PK Linearity of BMS-986460 Based on AUC(INF)
Up to approximately Day 7
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Sequence 1EXPERIMENTAL -
Part 1: Sequence 2EXPERIMENTAL -
Part 1: Sequence 3EXPERIMENTAL -
Part 2: Treatment AEXPERIMENTAL -
Part 2: Treatment BEXPERIMENTAL -
Part 2: Optional Treatment CEXPERIMENTAL -
Part 2: Optional Treatment DEXPERIMENTAL -
Part 2: Optional Treatment EEXPERIMENTAL -
Administration of BMS-986460EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986460DRUGSpecified dose on specified days.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, echocardiogram or clinical laboratory assessments, as determined by the investigator. * Participants must have a Bo...

Countries:United StatesCanadaFrance
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Recent Changes (Last 90 Days)

LOWAug 11, 2026NCT06067841lastUpdatePostDate: changed
LOWAug 11, 2026NCT06067841lastUpdatePostDate: changed
LOWAug 11, 2026NCT06067841lastUpdatePostDate: changed

Frequently asked questions about BMS-986460

What is BMS-986460 used for?

BMS-986460 is an investigational small molecule being studied for metastatic castration-resistant prostate cancer. It is also being evaluated in healthy volunteers to assess the safety, tolerability, drug levels, and relative biological availability of alternate formulations. The drug is in Phase 1 clinical development and is not yet approved.

Who makes BMS-986460?

BMS-986460 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with metastatic castration-resistant prostate cancer and in healthy volunteers.

What phase is BMS-986460 in?

BMS-986460 is in Phase 1 clinical development. It is being studied in two Phase 1 trials: one in patients with metastatic castration-resistant prostate cancer and one in healthy adult male participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is BMS-986460 in?

BMS-986460 is being studied in two clinical trials. NCT06067841 is a Phase 1 study in participants with metastatic castration-resistant prostate cancer, currently recruiting in the United States, Canada, and France. NCT06877702 is a completed Phase 1 study in healthy adult male participants in the United States.

Is BMS-986460 the same as any other drug?

No alternative names for BMS-986460 have been disclosed. The drug is identified solely by its development code BMS-986460 in clinical trial registrations and by Bristol-Myers Squibb. It is a distinct investigational small molecule being evaluated for metastatic castration-resistant prostate cancer.