Recruiting
Phase 1

BMS-986460

Sponsor:

Bristol-Myers Squibb

Code:

NCT06067841

Conditions

Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986460

Study Details

Brief 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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Study ID

NCT06067841

Start date

Oct 18, 2023

Status verified date

Aug, 2026

Completion date

Jul 27, 2031

Anticipated

Primary completion date

Aug 24, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Administration of BMS-986460

Interventions

BMS-986460

Specified dose on specified days.

Primary outcome measure

  • Number of participants with adverse events (AEs) [ Time Frame: Up to 112 weeks ]
  • Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 112 weeks ]
  • Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria [ Time Frame: Up to 28 days ]
  • Number of participants with AEs leading to study intervention discontinuation [ Time Frame: Up to 104 weeks ]
  • Number of deaths [ Time Frame: Up to 108 weeks ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Stanford Cancer Center

Recruiting

Palo Alto, California, United States, 94304

Contacts

Sandhya Srinivas, Site 0004

650-725-2078

Florida Cancer Specialists Sarasota Drug Development Unit

Recruiting

Sarasota, Florida, United States, 34232

Contacts

Manish Patel, Site 0007

941-377-9993

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Atish Choudhury, Site 0003

000-000-0000

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Dana Rathkopf, Site 0002

646-422-4379

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Andrew Armstrong, Site 0001

919-668-8797

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

David Sommerhalder, Site 0008

210-580-9500

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Ruben Raychaudhuri, Site 0005

206-618-8002

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Prostate Cancer
  • Castration-resistant prostate cancer
  • Adenocarcinoma of the prostate
  • Prostatic Neoplasms Castration-Resistant
  • Neoplasms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-10.