A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
Recruiting · NCT06067841 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
BMS-986460
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
- ther protocol-defined inclusion/exclusion criteria apply
Where it is running
15 locations listed across 7 US 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
- Duke Cancer Institute - Durham, North Carolina, United States
- Local Institution - 0006 - San Antonio, Texas, United States
- NEXT Oncology - San Antonio, Texas, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Local Institution - 0017 - Paris, France
- Local Institution - 0018 - Bordeaux, Aquitaine, France
- Centre Leon Berard - Lyon Cedex08, Auvergne-Rhône-Alpes, France
- Institut Paoli-Calmettes - Marseille, Nan, France
- Local Institution - 0009 - Toronto, Ontario, Canada
- Local Institution - 0011 - Montreal, Quebec, Canada
- Gustave Roussy - Villejuif, Val-de-Marne, France