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

Study Overview
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Brief Summary
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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.

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

Conditions
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Metastatic Castration-resistant Prostate Cancer

Intervention / Treatment
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* Drug: BMS-986460


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Administration of BMS-986460<br> | Drug: BMS-986460<br>* Specified dose on specified days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of participants with AEs leading to study intervention discontinuation |  | Up to 104 weeks | 
| Number of deaths |  | Up to 212 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) |  | Up to 13 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 | 
| Number of participants with soft tissue response |  | Up to 108 weeks | 
| Duration of response (DOR) |  | Up to 108 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Castration-resistant prostate cancer, Adenocarcinoma of the prostate, Prostatic Neoplasms Castration-Resistant, Neoplasms