A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer

NCT ID: NCT06067841

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-18

Study Completion Date

2031-07-27

Brief Summary

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The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate Cancer.

Detailed Description

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Conditions

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Metastatic Castration-resistant Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Administration of BMS-986460

Group Type EXPERIMENTAL

BMS-986460

Intervention Type DRUG

Specified dose on specified days.

Interventions

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BMS-986460

Specified dose on specified days.

Intervention Type DRUG

Eligibility Criteria

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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
* Participant must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)

Exclusion Criteria

* Participant must not have history of brain metastases.
* Participant must not have impaired cardiac function or clinically significant cardiac disease.
* Participant must not have any significant medical condition, including active or uncontrolled infection, psychiatric illness, or the presence of laboratory abnormalities, which places the participant at unacceptable risk or prevent participation in the study based on Investigator assessment.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0004

Palo Alto, California, United States

Site Status

Local Institution - 0007

Sarasota, Florida, United States

Site Status

Local Institution - 0003

Boston, Massachusetts, United States

Site Status

Local Institution - 0002

New York, New York, United States

Site Status

Local Institution - 0001

Durham, North Carolina, United States

Site Status

Local Institution - 0008

San Antonio, Texas, United States

Site Status

Local Institution - 0005

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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2024-513987-24

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1307-2450

Identifier Type: OTHER

Identifier Source: secondary_id

CA125-1008

Identifier Type: -

Identifier Source: org_study_id

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