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AZD9750 · 1 trial · 1 indication
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...
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AZD9750 is an investigational small molecule being developed by AstraZeneca PLC for the treatment of prostate cancer. It is in Phase 1 clinical development and is not yet approved for any indication. It is being studied in patients with metastatic prostate cancer, a form of advanced disease that has spread beyond the prostate gland.
AZD9750 is being studied for use in metastatic prostate cancer. The single active trial enrolls adult male patients aged 18 years and older with this condition and evaluates the drug given with or without other anticancer drugs. It remains investigational and has not been approved for any use.
AZD9750 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the Phase 1 clinical program evaluating the compound in metastatic prostate cancer. The drug is an investigational small molecule and is not yet commercially available.
AZD9750 is in Phase 1 clinical development. One Phase 1 trial is currently active and recruiting has closed, with no completed trials reported. Because it is still in early-stage testing, AZD9750 is investigational and has not received FDA approval for any indication.
AZD9750 is being evaluated in one Phase 1 trial, NCT07336446, titled a study 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. The trial is active but not recruiting, has enrolled 6 participants, and is controlled and randomized without blinding. It is running in the United States, Australia, Japan, and the United Kingdom.