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Completed

NCT Number: NCT04428788

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

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms, Castration-Resistant Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 116, Stanford, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CC-94676

Drug

Specified dose on specified days

Other names: BMS-986365

CC1083611

Drug

Specified dose on specified days

Other names: BMS-986409

CC1083610

Drug

Specified dose on specified days

Other names: BMS-986410

Primary outcomes

  1. Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria

    Time frame: From the time of consent at screening until 28 days after thesubject discontinues study treatment.

  2. Dose-limiting toxicity (DLT)

    Time frame: Up to 35 days

  3. Non-tolerated dose (NTD)

    Time frame: Up to 35 days

  4. Maximum tolerated dose (MTD)

    Time frame: Up to 35 days

Secondary outcomes

  1. Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)

    Time frame: Up to approximately 4 years

  2. Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

    Time frame: Up to approximately 4 years

  3. Duration of response (DOR)

    Time frame: Up to approximately 4 years

  4. Proportion of participants alive and not progressed at 6 months

    Time frame: Up to 6 months after treatment is discontinued

  5. PSA Progression Free Survival (PFS)

    Time frame: Up to approximately 4 years

  6. Radiographic progression free survival (rPFS)

    Time frame: Up to approximately 4 years

  7. Overall survival (OS)

    Time frame: Up to approximately 4 years

  8. Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population

    Time frame: Up to approximately 4 years

  9. Pharmacokinetics - Area under the plasma concentration time curve (AUC)

    Time frame: Up to 35 days

  10. Pharmacokinetics - Maximum plasma concentration (Cmax)

    Time frame: Up to 35 days

  11. Pharmacokinetics - Time to Cmax (Tmax)

    Time frame: Up to 35 days

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2020
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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