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NCT06067841PHASE1Recruiting

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

Bristol-Myers Squibb

Start Date

10/18/2023

Completion Date

7/27/2031

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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. Other protocol-defined inclusion/exclusion criteria apply

Interventions

DRUG

BMS-986460

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Conditions

Metastatic Castration-resistant Prostate Cancer

Locations

Stanford Cancer Center

Palo Alto, California 94304

United States

Florida Cancer Specialists Sarasota Drug Development Unit

Sarasota, Florida 34232

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Duke Cancer Institute

Durham, North Carolina 27710

United States

Local Institution - 0006

San Antonio, Texas 78229

United States

NEXT Oncology

San Antonio, Texas 78229

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States