Study to Evaluate the Safety and Tolerability of CC-94676 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 CC-94676 in men with progressive metastatic castration resistant prostate cancer.

Official Title
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A Phase 1, Multi-center, Open-label, Dose Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cc-94676 in Subjects With Metastatic Castration-resistant Prostate Cancer

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: CC-94676
* Drug: CC1083611
* Drug: CC1083610


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have histologically or cytologically confirmed adenocarcinoma of the prostate Progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Exclusion Criteria: Prior treatment with an androgen receptor (AR) degrader Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 1 year prior to the first dose of IP Clinically significant venous thromboembolism within 3 months prior to the first dose of IP Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness 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 CC-94676, CC1083611, and CC1083610<br> | Drug: CC-94676<br>* Specified dose on specified days<br>* Other names: BMS-986365;Drug: CC1083611<br>* Specified dose on specified days<br>* Other names: BMS-986409;Drug: CC1083610<br>* Specified dose on specified days<br>* Other names: BMS-986410;|

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) evaluated using the NCI CTCAE v5.0 criteria |  | From the time of consent at screening until 28 days after thesubject discontinues study treatment. | 
| Dose-limiting toxicity (DLT) |  | Up to 35 days | 
| Non-tolerated dose (NTD) |  | Up to 35 days | 
| Maximum tolerated dose (MTD) |  | Up to 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50) |  | Up to approximately 4 years | 
| Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) |  | Up to approximately 4 years | 
| Duration of response (DOR) |  | Up to approximately 4 years | 
| Proportion of participants alive and not progressed at 6 months |  | Up to 6 months after treatment is discontinued | 
| PSA Progression Free Survival (PFS) |  | Up to approximately 4 years | 
| Radiographic progression free survival (rPFS) |  | Up to approximately 4 years | 
| Overall survival (OS) |  | Up to approximately 4 years | 
| Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population |  | Up to approximately 4 years | 
| Pharmacokinetics - Area under the plasma concentration time curve (AUC) |  | Up to 35 days | 
| Pharmacokinetics - Maximum plasma concentration (Cmax) |  | Up to 35 days | 
| Pharmacokinetics - Time to Cmax (Tmax) |  | Up to 35 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, CC-94676, Castration-resistant prostate cancer, Adenocarcinoma of the prostate, Prostatic Neoplasms Castration-Resistant, Neoplasms