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CC-94676

Phase 3

Prostatic Neoplasms | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Sep 30, 2026

CC-94676 development status

Highest phase Phase 3 (NCT06764485)
Phase scored for BMYPhase 1
Registered trials 5 across 1 sponsor since Jun 2020

CC-94676 target and mechanism

ModalitySmall molecule

Also known as BMS-986365, AR-LDD

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment1,091

FDA Designations

No designations recorded

CC-94676 clinical trials

CC-94676 · 2 trials · 2 indications

Phase 3 1Phase 1 1
NCT06764485A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate CancerMetastatic Castration-resistant Prostate Cancer
ACTIVE NOT_RECRUITING960 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer
Metastatic Castration-resistant Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteria
Up to 4 years
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

Overall Survival (OS)
Up to 4 years
Recommended dose of BMS-986365 for Part 2
Up to approximately 1.5 years
Progression-free survival (PFS)
Up to 4 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Dose 1EXPERIMENTAL -
Part 1: Dose 2EXPERIMENTAL -
Part 1: Comparator 1ACTIVE_COMPARATOREnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Part 1: Comparator 2ACTIVE_COMPARATOR -
Part 2: Dose SelectedEXPERIMENTAL -
Part 2: Comparator 1ACTIVE_COMPARATOREnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Part 2: Comparator 2ACTIVE_COMPARATOR -
Administration of CC-94676, CC1083611, and CC1083610EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986365DRUGSpecified dose on specified days
EnzalutamideDRUGSpecified dose on specified days
AbirateroneDRUGSpecified dose on specified days
DocetaxelDRUGSpecified dose on specified days
Predinsone/PrednisoloneDRUGSpecified dose on specified days
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 Sites227

Inclusion Criteria * Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features. * Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft ...

Countries:United StatesArgentinaAustraliaAustriaBrazilCanadaChileChinaCzechiaDenmarkFinlandFranceGermanyIrelandIsraelItalyMexicoPolandPuerto RicoRomaniaSlovakiaSouth KoreaSpainSwedenTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)

LOWSep 30, 2026NCT06764485lastUpdatePostDate: changed
LOWSep 30, 2026NCT06764485lastUpdatePostDate: changed
MEDIUMSep 8, 2026NCT06764485Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMSep 8, 2026NCT06764485Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWAug 19, 2026NCT06764485lastUpdatePostDate: changed
LOWAug 19, 2026NCT06764485lastUpdatePostDate: changed
LOWAug 19, 2026NCT06764485lastUpdatePostDate: changed
LOWJul 22, 2026NCT06764485lastUpdatePostDate: changed
LOWJul 22, 2026NCT06764485lastUpdatePostDate: changed

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.