Status:
ACTIVE_NOT_RECRUITING
A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Metastatic Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 27 2031
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06067841
Start Date
October 18 2023
End Date
July 27 2031
Last Update
October 3 2025
Active Locations (7)
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1
Local Institution - 0004
Palo Alto, California, United States, 94304
2
Local Institution - 0007
Sarasota, Florida, United States, 34232
3
Local Institution - 0003
Boston, Massachusetts, United States, 02215
4
Local Institution - 0002
New York, New York, United States, 10065