Clinical trial · Interventional
Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer
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
NCT04428788CI-TRIAL-00099480completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CC1083610 | Drug | — | UNRESOLVED |
| CC1083611 | Drug | — | UNRESOLVED |
| CC-94676 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Administration of CC-94676, CC1083611, and CC1083610
- interventionNames
- Drug: CC-94676
- Drug: CC1083611
- Drug: CC1083610
Primary outcomes (4)
- measure
- Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
- timeFrame
- From the time of consent at screening until 28 days after thesubject discontinues study treatment.
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- Up to 35 days
- measure
- Non-tolerated dose (NTD)
- timeFrame
- Up to 35 days
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRathkopf DE, Patel MR, Choudhury AD, Rasco D, Lakhani N, Hawley JE, Srinivas S, Aparicio A, Narayan V, Runcie KD, Emamekhoo H, Reichert ZR, Nguyen MH, Wells AL, Kandimalla R, Liu C, Suryawanshi S, Han J, Wu J, Arora VK, Pourdehnad M, Armstrong AJ. Safety and clinical activity of BMS-986365 (CC-94676), a dual androgen receptor ligand-directed degrader and antagonist, in heavily pretreated patients with metastatic castration-resistant prostate cancer. Ann Oncol. 2025 Jan;36(1):76-88. doi: 10.1016/j.annonc.2024.09.005. Epub 2024 Sep 16. PMID 39293515