Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04495179 | A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC. | PHASE2 | COMPLETED | 30 | — | — | Aug 4, 2020 | Aug 8, 2022 | Aug 9, 2023 | 16 | United States, Belgium +3 |
rPFS was defined as the time from first dose to radiographic progression, assessed by the Investigator per RECIST 1.1 (soft tissue) and PCWG3 (Prostate Cancer Working Group 3) criteria \[bone\] or death from any cause, whichever occurred first.
| Arm | Type | Description |
|---|---|---|
| Arm A: AZD4635 + durvalumab | EXPERIMENTAL | AZD4635 plus durvalumab (Arm A) will consist of participants with mCRPC previously treated with one or more approved NHAs (eg, abiraterone acetate, enzalutamide, apalutamide and/or darolutamide), and one or more taxanes, or participants who are taxane ineligible. |
| Arm B: AZD4635 + durvalumab + cabazitaxel | EXPERIMENTAL | AZD4635 plus durvalumab plus cabazitaxel (Arm B) will consist of participants with mCRPC previously treated with docetaxel and one prior NHA (either abiraterone acetate or enzalutamide but not both (prior apalutamide is not allowed in Arm B). |
| Name | Type | Description |
|---|---|---|
| AZD4635 | DRUG | Subjects will receive AZD4635 orally daily |
| Durvalumab | DRUG | Subjects will receive intravenous durvalumab every 4 weeks for Arm A and every 3 weeks for Arm B. |
| Cabazitaxel | DRUG | Subjects will receive intravenous cabazitaxel every 3 weeks |
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate. 2. Known castrate-resistant disease. 3. Evidence of disease progression ≤6 months. 4. Body weight \>30 kg at screening. 5. Willingness to adhere to the study treatment-specific contraception requirements. 6. Adequate bo...