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CC-94676

Phase 1

Prostatic Neoplasms | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Dec 22, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment131

FDA Designations

No designations recorded

Clinical trial landscape

CC-94676 · 1 trial · 1 indication

Phase 1 1
NCT04428788Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate CancerProstatic Neoplasms
COMPLETED131 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms
NCT04428788131
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Administration of CC-94676, CC1083611, and CC1083610EXPERIMENTAL -

Interventions

NameTypeDescription
CC-94676DRUGSpecified dose on specified days
CC1083611DRUGSpecified dose on specified days
CC1083610DRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites19

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...

Countries:United States
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Frequently asked questions about CC-94676

What is CC-94676 used for?

CC-94676 is an investigational small molecule being studied for the treatment of prostatic neoplasms, specifically metastatic castration-resistant prostate cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes CC-94676?

CC-94676 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY.

What phase is CC-94676 in?

CC-94676 is in Phase 1 clinical development. A Phase 1 study evaluating its safety and tolerability in participants with metastatic castration-resistant prostate cancer has been completed.

What clinical trials is CC-94676 in?

CC-94676 has one completed clinical trial, identified as NCT04428788. This Phase 1 study evaluated the safety and tolerability of CC-94676 in 131 male participants with metastatic castration-resistant prostate cancer in the United States.

Is CC-94676 FDA approved?

CC-94676 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, and it remains in clinical development for the treatment of metastatic castration-resistant prostate cancer.