A Phase 1, Open-label Study of BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer

Bristol-Myers Squibb8 sites in 1 country140 target enrollmentOctober 18, 2023

ConditionsMetastatic Castration-resistant Prostate Cancer

InterventionsBMS-986460

Overview

Phase: Phase 1
Intervention: BMS-986460
Conditions: Metastatic Castration-resistant Prostate Cancer
Sponsor: Bristol-Myers Squibb
Enrollment: 140
Locations: 8
Primary Endpoint: Number of participants with adverse events (AEs)
Status: Recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 18, 2023

End Date

July 27, 2031

Last Updated

2 months ago

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

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
•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

Arms & Interventions

Administration of BMS-986460

Intervention: BMS-986460

Outcomes

Primary Outcomes

Number of participants with adverse events (AEs)

Time Frame: Up to 112 weeks

Number of participants with serious adverse events (SAEs)

Time Frame: Up to 112 weeks

Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria

Time Frame: Up to 28 days

Number of participants with AEs leading to study intervention discontinuation

Time Frame: Up to 104 weeks

Number of deaths

Time Frame: Up to 108 weeks

Secondary Outcomes

Maximum concentration (Cmax)(Up to 13 weeks)
Number of participants with soft tissue response(Up to 108 weeks)
Duration of response (DOR)(Up to 108 weeks)
Time of maximum concentration (Tmax)(Up to 13 weeks)
Area under the plasma concentration-time curve (AUC)(Up to 13 weeks)
Number of participants with a confirmed prostate specific antigen decline of ≥ 30% from baseline response rate(Up to 108 weeks)