Assessing BMS-986460 for advanced prostate cancer
A Phase 1, Open-label Study of BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
This study is testing a new treatment called BMS-986460 to see if it can help men with advanced prostate cancer who haven't responded to other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 8 sites (Palo Alto, California and 7 other locations) |
| Trial ID | NCT06067841 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and preliminary efficacy of BMS-986460 in men diagnosed with metastatic castration-resistant prostate cancer. Participants must have confirmed adenocarcinoma of the prostate and have previously undergone androgen deprivation therapy along with at least one secondary hormonal treatment. The study aims to gather data on how well this new treatment works in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are men with confirmed metastatic castration-resistant prostate cancer who have progressed on prior treatments.
Not a fit: Patients with a history of brain metastases or significant cardiac issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer that is resistant to standard therapies.
How similar studies have performed: Other studies have shown promise with similar approaches in treating advanced prostate cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California and 7 other locations
- Stanford Cancer Center — Palo Alto, California, United States (Recruiting)
- Florida Cancer Specialists Sarasota Drug Development Unit — Sarasota, Florida, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Duke Cancer Institute — Durham, North Carolina, United States (Recruiting)
- Local Institution - 0006 — San Antonio, Texas, United States (Withdrawn)
- NEXT Oncology — San Antonio, Texas, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.