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NCT Number: NCT06067841

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

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.

Recruiting

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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Prostatic Neoplasms, Castration-Resistant Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Stanford Cancer Center, Palo Alto, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986460

Drug

Specified dose on specified days.

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 112 weeks

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 112 weeks

  3. Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria

    Time frame: Up to 28 days

  4. Number of participants with AEs leading to study intervention discontinuation

    Time frame: Up to 104 weeks

  5. Number of deaths

    Time frame: Up to 108 weeks

Secondary outcomes

  1. Maximum concentration (Cmax)

    Time frame: Up to 13 weeks

  2. Time of maximum concentration (Tmax)

    Time frame: Up to 13 weeks

  3. Area under the plasma concentration-time curve (AUC)

    Time frame: Up to 13 weeks

  4. Number of participants with a confirmed prostate specific antigen decline of ≥ 30% from baseline response rate

    Time frame: Up to 108 weeks

  5. Number of participants with soft tissue response

    Time frame: Up to 108 weeks

  6. Duration of response (DOR)

    Time frame: Up to 108 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2029
Study completion
2031
First posted
Oct 5, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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