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CC-94676

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment131
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04428788Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate CancerPHASE1 COMPLETED 131 — — Jun 22, 2020Oct 28, 2025Dec 22, 202519 United States
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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 — 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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