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A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer

NCT06067841 · Bristol-Myers Squibb
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Official title
A Phase 1, Open-label Study of BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
About this study
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 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
Enrollment target: 140 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-10-18
Estimated completion: 2031-07-27
Last updated: 2026-02-04
Interventions
Drug: BMS-986460
Primary outcomes
  • Number of participants with adverse events (AEs) (Up to 112 weeks)
  • Number of participants with serious adverse events (SAEs) (Up to 112 weeks)
  • Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria (Up to 28 days)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (8)
Stanford Cancer CenterRecruiting
Palo Alto, California, United States
Florida Cancer Specialists Sarasota Drug Development UnitRecruiting
Sarasota, Florida, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Duke Cancer InstituteRecruiting
Durham, North Carolina, United States
Local Institution - 0006Withdrawn
San Antonio, Texas, United States
NEXT OncologyRecruiting
San Antonio, Texas, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer · TrialPath