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BMS-986460

Phase 1

Metastatic Castration-resistant Prostate Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Aug 10, 2026

BMS-986460 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Oct 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

BMS-986460 clinical trials

BMS-986460 · 1 trial · 1 indication

Phase 1 1
NCT06067841A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate CancerMetastatic Castration-resistant Prostate Cancer
RECRUITING140 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

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

Maximum concentration (Cmax)
Up to 13 weeks
Time of maximum concentration (Tmax)
Up to 13 weeks
Area under the plasma concentration-time curve (AUC)
Up to 13 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Administration of BMS-986460EXPERIMENTAL -

Interventions

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

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Participant must have histologically or cytologically confirmed adenocarcinoma of the prostate. * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Participant must have prostate specific antigen (PSA) of ≥ 2 ng/mL at Screening * P...

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 the treatment of metastatic castration-resistant prostate cancer, an advanced form of prostate cancer that has spread beyond the prostate and continues to progress despite androgen deprivation therapy. It is in Phase 1 clinical development and has not been approved for any indication.

Who is developing BMS-986460?

BMS-986460 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sponsor of the Phase 1 clinical program evaluating the compound in metastatic castration-resistant prostate cancer.

What phase is BMS-986460 in?

BMS-986460 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 1 program is currently recruiting participants and is designed to assess the compound in patients with metastatic castration-resistant prostate cancer.

What clinical trial is BMS-986460 in?

BMS-986460 is being evaluated in the Phase 1 trial NCT06067841, titled A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer. The trial is currently recruiting, plans to enroll 140 participants, and is open at sites in the United States, Canada, and France.

Who can enroll in the BMS-986460 clinical trial?

The Phase 1 trial NCT06067841 enrolls male participants aged 18 years and older with metastatic castration-resistant prostate cancer. It is an uncontrolled, open-label study that does not include healthy volunteers, and enrollment is limited to patients with the specified condition.