Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT04428788 | Completed Phase 1 FDA Drug

• 2 other identifiers: CC-94676-PCA-001U1111-1251-9174
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Prostatic Neoplasms

Keywords

Prostate Cancer; CC-94676; Castration-resistant prostate cancer; Adenocarcinoma of the prostate; Prostatic Neoplasms Castration-Resistant; Neoplasms

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• 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

Study Arms (1)

Administration of CC-94676, CC1083611, and CC1083610

EXPERIMENTAL

Drug: CC-94676; Drug: CC1083611; Drug: CC1083610

Interventions

CC-94676 DRUG

Specified dose on specified days

Also known as: BMS-986365

Administration of CC-94676, CC1083611, and CC1083610

CC1083611 DRUG

Specified dose on specified days

Also known as: BMS-986409

Administration of CC-94676, CC1083611, and CC1083610

CC1083610 DRUG

Specified dose on specified days

Also known as: BMS-986410

Administration of CC-94676, CC1083611, and CC1083610

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (19)

Local Institution - 116

Stanford, California, 94305-5826, United States

Location

Local Institution - 122

Washington D.C., District of Columbia, 20010, United States

Location

Local Institution - 103

Sarasota, Florida, 34232, United States

Location

Local Institution - 121

Thomasville, Georgia, 31792, United States

Location

Local Institution - 108

Baltimore, Maryland, 21287, United States

Location

Local Institution - 104

Boston, Massachusetts, 02215, United States

Location

Local Institution - 117

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 102

Grand Rapids, Michigan, 49546, United States

Location

Local Institution - 112

New York, New York, 10029, United States

Location

Local Institution - 109

New York, New York, 10032, United States

Location

Local Institution - 105

New York, New York, 10065, United States

Location

Local Institution - 106

Durham, North Carolina, 27710, United States

Location

Local Institution - 120

Allentown, Pennsylvania, 18103, United States

Location

Local Institution - 113

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution - 107

Dallas, Texas, 75235, United States

Location

Local Institution - 119

Houston, Texas, 77030, United States

Location

Local Institution - 101

San Antonio, Texas, 78229, United States

Location

Local Institution - 115

Seattle, Washington, 98109, United States

Location

Local Institution - 111

Madison, Wisconsin, 53792, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 11, 2020
• Study Start: June 22, 2020
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (19)