A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
Phase 1
Recruiting
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- Registration Number
- NCT06067841
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 90
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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Administration of BMS-986460 BMS-986460 -
- Primary Outcome Measures
Name Time Method Number of participants with AEs leading to study intervention discontinuation Up to 104 weeks Number of participants with adverse events (AEs) Up to 112 weeks Number of deaths Up to 212 weeks Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria Up to 28 days Number of participants with serious adverse events (SAEs) Up to 112 weeks
- Secondary Outcome Measures
Name Time Method Maximum concentration (Cmax) Up to 13 weeks Number of participants with soft tissue response Up to 108 weeks Duration of response (DOR) Up to 108 weeks Time of maximum concentration (Tmax) Up to 13 weeks Area under the plasma concentration-time curve (AUC) Up to 13 weeks Number of participants with a confirmed prostate specific antigen decline of ≥ 30% from baseline response rate Up to 108 weeks
Trial Locations
- Locations (8)
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
Local Institution - 0006
🇺🇸San Antonio, Texas, United States
NEXT Oncology
🇺🇸San Antonio, Texas, United States
Stanford Cancer Center
🇺🇸Palo Alto, California, United States
Florida Cancer Specialists Sarasota Drug Development Unit
🇺🇸Sarasota, Florida, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States