NCT06067841PHASE1Recruiting
A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
Bristol-Myers Squibb
Start Date
10/18/2023
Completion Date
7/27/2031
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
Age Range: 18 years to No maximum
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
Interventions
DRUG
BMS-986460
Conditions
Metastatic Castration-resistant Prostate Cancer
Locations
Stanford Cancer Center
Palo Alto, California 94304
United States
Florida Cancer Specialists Sarasota Drug Development Unit
Sarasota, Florida 34232
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Duke Cancer Institute
Durham, North Carolina 27710
United States
Local Institution - 0006
San Antonio, Texas 78229
United States
NEXT Oncology
San Antonio, Texas 78229
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States