Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986365 · 3 trials · 3 indications
Part A and B
Part A and B
Part A and B
Part A and B
Part A and B
Part A
Part A and B
Part A
Part A
Part A and B
Part A
| 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 | - |
| Part A | EXPERIMENTAL | - |
| Part B - Arm 1 | EXPERIMENTAL | - |
| Part B - Arm 2 | EXPERIMENTAL | - |
| Part 1: Cohort 1 BMS-986365 Dose 1 | EXPERIMENTAL | - |
| Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1 | EXPERIMENTAL | - |
| Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2 | EXPERIMENTAL | - |
| Part 1: Cohort 3 BMS-986365 Dose 4 | EXPERIMENTAL | - |
| Part 1: Cohort 6 BMS-986365 Dose 5 | EXPERIMENTAL | - |
| Part 1: Cohort 7 BMS-986365 Dose 6 | EXPERIMENTAL | - |
| Part 1: Cohort 8 BMS-986365 Dose 7 | EXPERIMENTAL | - |
| Part 1: Cohort 9 BMS-986365 Dose 8 | EXPERIMENTAL | - |
| Part 2: Cohort 4 BMS-986365 Dose 9 Fasted | EXPERIMENTAL | - |
| Part 2: Cohort 4 BMS-986365 Dose 10 Fed | EXPERIMENTAL | - |
| Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365 | 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 |
| [14C] BMS-986365 | DRUG | Specified dose on specified days. |
| [14C] BMS-986409 + BMS-986410 | DRUG | Specified dose on specified days |
| [14C] BMS-986410 + BMS-986409 | DRUG | Specified dose on specified days |
| Rabeprazole | 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 an investigational small molecule being studied for metastatic castration-resistant prostate cancer. It is also being evaluated in healthy participants and healthy volunteers in early-phase trials to assess safety, drug levels, and bioavailability. The drug is not approved and remains in clinical development.
BMS-986365 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials of the drug in the United States and multiple other countries.
BMS-986365 is in Phase 1 clinical development for healthy participants and healthy volunteers, with two completed Phase 1 trials. A Phase 3 trial in metastatic castration-resistant prostate cancer is currently recruiting participants. The drug is investigational and not FDA approved.
BMS-986365 has three clinical trials. NCT06417229 and NCT06433505 are completed Phase 1 studies in healthy male participants. NCT06764485 is a recruiting Phase 3 trial comparing BMS-986365 to investigator's choice of therapy in metastatic castration-resistant prostate cancer, with an enrollment of 960.
No alternative names for BMS-986365 have been disclosed in the available clinical trial information. The drug is identified solely by its compound number, BMS-986365, in the registered studies.