A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
Conditions
Metastatic Castration-resistant Prostate CancerDrugs
BMS-986460Summary
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-986460Description:
Specified dose on specified days.
Outcome Measures
Primary Outcome Measures
Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria
Number of participants with AEs leading to study intervention discontinuation
Number of deaths
Secondary Outcome Measures
Maximum concentration (Cmax)
Time of maximum concentration (Tmax)
Area under the plasma concentration-time curve (AUC)
Number of participants with a confirmed prostate specific antigen decline of u2265 30% from baseline response rate
Number of participants with soft tissue response
Duration of response (DOR)
Timeline
Last Updated
August 28, 2024Start Date
October 5, 2023Today
January 16, 2025Completion Date ( Estimated )
January 16, 2029
Sponsors of this trial
Lead Sponsor
Bristol-Myers Squibb