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Also known as CC-94676
BMS-986365 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose 1 | EXPERIMENTAL | - |
| Part 1: Dose 2 | EXPERIMENTAL | - |
| Part 1: Comparator 1 | ACTIVE_COMPARATOR | Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone |
| Part 1: Comparator 2 | ACTIVE_COMPARATOR | - |
| Part 2: Dose Selected | EXPERIMENTAL | - |
| Part 2: Comparator 1 | ACTIVE_COMPARATOR | Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone |
| Part 2: Comparator 2 | ACTIVE_COMPARATOR | - |
| Administration of CC-94676, CC1083611, and CC1083610 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986365 | DRUG | Specified dose on specified days |
| Enzalutamide | DRUG | Specified dose on specified days |
| Abiraterone | DRUG | Specified dose on specified days |
| Docetaxel | DRUG | Specified dose on specified days |
| Predinsone/Prednisolone | DRUG | Specified dose on specified days |
| CC-94676 | DRUG | Specified dose on specified days |
| CC1083611 | DRUG | Specified dose on specified days |
| CC1083610 | DRUG | Specified dose on specified days |
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 ...
BMS-986365 is being developed for the treatment of metastatic castration-resistant prostate cancer, an advanced form of prostate cancer that has spread beyond the prostate and no longer responds to androgen deprivation therapy. It is an investigational small molecule and has not been approved for any indication.
BMS-986365 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sponsor of the clinical program evaluating the drug in metastatic castration-resistant prostate cancer.
BMS-986365 is in Phase 3 clinical development. The program includes one active Phase 3 trial that is currently not recruiting, with a planned enrollment of 960 participants. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.
BMS-986365 is being evaluated in the Phase 3 trial NCT06764485, titled 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. The trial is active but not recruiting, is randomized and active-controlled, and has a planned enrollment of 960 male participants aged 18 years and older across 26 countries.
BMS-986365 is a small molecule therapeutic being developed for metastatic castration-resistant prostate cancer. It is designed to target the androgen receptor signaling pathway, a key driver of prostate cancer growth. The specific molecular target and mechanism of action have not been publicly disclosed.