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

Clinicaltrials.gov ID: NCT06067841
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 90

Conditions

Metastatic Castration-resistant Prostate Cancer

Drugs

BMS-986460

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.

Locations

7 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Sandhya Srinivas, Site 0004
  • 650-725-2078

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Manish Patel, Site 0007
  • 941-377-9993

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Atish Choudhury, Site 0003
  • 000-000-0000

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Dana Rathkopf, Site 0002
  • 646-422-4379

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Andrew Armstrong, Site 0001
  • 919-668-8797

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • David Sommerhalder, Site 0008
  • 210-580-9500

Study Director

  • Bristol-Myers Squibb

Status

  • RECRUITING

Contact Person

  • Jessica Hawley, Site 0005
  • 206-606-2284

Study Director

  • Bristol-Myers Squibb

Eligibility 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

Study Plan

Administration of BMS-986460

  • DRUG:

    BMS-986460

    Description:

    Specified dose on specified days.

Outcome Measures

Primary Outcome Measures

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 212 weeks

Secondary Outcome Measures

Maximum concentration (Cmax)

Time Frame: Up to 13 weeks

Time of maximum concentration (Tmax)

Time Frame: Up to 13 weeks

Area under the plasma concentration-time curve (AUC)

Time Frame: Up to 13 weeks

Number of participants with a confirmed prostate specific antigen decline of u2265 30% from baseline response rate

Time Frame: Up to 108 weeks

Number of participants with soft tissue response

Time Frame: Up to 108 weeks

Duration of response (DOR)

Time Frame: Up to 108 weeks

Timeline

  • Last Updated
    August 28, 2024
  • Start Date
    October 5, 2023
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    January 16, 2029

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