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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07336446 | A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs | PHASE1 | RECRUITING | 300 | — | — | Jan 27, 2026 | Jan 26, 2029 | May 1, 2026 | 18 | United States, Australia +6 |
To evaluate the safety and tolerability and determine the MTD and/or the RDE(s)/RP2D of AZD9750 as a monotherapy and in combination with other anticancer agents in participants with mCRPC. A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.
The number of participants with adverse events and with serious adverse events will be assessed.
The number of participants with clinically significant changes from baseline in vital signs will be assessed.
The number of participants with clinically significant changes from baseline in vital signs will be assessed.
The number of participants with clinically significant changes from baseline in physical examination will be assessed.
The number of participants with clinically significant changes from baseline in ECOG PS will be assessed.
The number of participants with clinically significant changes from baseline in ECGs will be assessed.
The number of participants with clinically significant changes from baseline in laboratory parameters will be assessed.
To evaluate the preliminary antitumour efficacy of AZD9750 as monotherapy and in combination with other anticancer agents in participants with mCRPC.
| Arm | Type | Description |
|---|---|---|
| Module 1 / Part A1 | EXPERIMENTAL | AZD9750 Monotherapy (Dose Escalation) - No randomization |
| Module 1 / Part A2 | EXPERIMENTAL | AZD9750 Monotherapy (Backfills) - No randomization |
| Module 1 / Part B1 | EXPERIMENTAL | AZD9750 Monotherapy (Dose Optimization) - Randomization |
| Module 1 Part B2 | EXPERIMENTAL | AZD9750 Monotherapy (Dose Expansion) - No randomization |
| Module 1 / Part B3 | EXPERIMENTAL | AZD9750 Monotherapy (Dose Expansion) - No randomization |
| Module 2 / Part A | EXPERIMENTAL | AZD9750 + Saruparib (Combination Dose Finding) - No Randomization |
| Module 2/ Part B | EXPERIMENTAL | AZD9750 + Saruparib (Combination Dose Expansion) - No Randomization |
| Name | Type | Description |
|---|---|---|
| AZD9750 | DRUG | AR-PROTAC |
| AZD5305 | DRUG | PARP1-selective inhibitor |
* Inclusion Criteria: * Participant must be ≥18 years or the legal age at the time of signing the informed consent form. * Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate. * Documented metastatic disease. * Serum testosterone levels ≤ 50 ng/dL. * Evid...