Clinical trial Recruiting at 10 sites Phase 1 Interventional Ages 18 and up Men only

Assessing BMS-986460 for advanced prostate cancer

Official title: A Phase 1, Open-label Study of BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer

Run by Bristol-Myers Squibb · NCT06067841 · Data updated 2026-11-12

This study is testing a new treatment called BMS-986460 to see if it can help men with advanced prostate cancer who haven't responded to other therapies.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment140 (estimated)
SponsorBristol-Myers Squibb
Industry-sponsored
Locations15 sites (Palo Alto, California and 14 other locations)
StatusRecruiting
StartedOctober 18, 2023
Main results expectedAugust 24, 2029
Study endsJuly 27, 2031
Registry record updatedAugust 10, 2026
Trial IDNCT06067841 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men with confirmed metastatic castration-resistant prostate cancer who have progressed on prior treatments.

Probably not a fit

Patients with a history of brain metastases or significant cardiac issues may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety, tolerability, and preliminary efficacy of BMS-986460 in men diagnosed with metastatic castration-resistant prostate cancer. Participants must have confirmed adenocarcinoma of the prostate and have previously undergone androgen deprivation therapy along with at least one secondary hormonal treatment. The study aims to gather data on how well this new treatment works in this specific patient population.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer that is resistant to standard therapies.

How similar studies have gone: Other studies have shown promise with similar approaches in treating advanced prostate cancer, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Stanford Cancer Center
    Palo Alto, California, United States
    Recruiting
  • Florida Cancer Specialists Sarasota Drug Development Unit
    Sarasota, Florida, United States
    Recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York, United States
    Recruiting
  • Duke Cancer Institute
    Durham, North Carolina, United States
    Recruiting
  • NEXT Oncology
    San Antonio, Texas, United States
    Recruiting
Show 9 more locations
  • Fred Hutchinson Cancer Center
    Seattle, Washington, United States
    Recruiting
  • Centre Leon Berard
    Lyon Cedex08, Auvergne-Rhône-Alpes, France
    Recruiting
  • Institut Paoli-Calmettes
    Marseille, Nan, France
    Recruiting
  • Gustave Roussy
    Villejuif, Val-de-Marne, France
    Recruiting
  • Local Institution - 0006
    San Antonio, Texas, United States
    Withdrawn
  • Local Institution - 0009
    Toronto, Ontario, Canada
    Not yet recruiting
  • Local Institution - 0011
    Montreal, Quebec, Canada
    Not yet recruiting
  • Local Institution - 0018
    Bordeaux, Aquitaine, France
    Not yet recruiting
  • Local Institution - 0017
    Paris, France
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.