In short
AZD9750 is an investigational chemical substance being studied for metastatic prostate cancer. It is given as a film-coated tablet by mouth and has no marketing authorisation in the product records, meaning it is not yet an approved medicine. The available trial record covers one completed Phase 1/2 study with 302 participants, testing AZD9750 alone or with another anticancer drug called saruparib.
Key points
- AZD9750 is an investigational oral drug with no marketing authorisation.
- It is being studied in metastatic prostate cancer, specifically metastatic castration-resistant prostate cancer (mCRPC).
- The completed Phase 1/2 trial enrolled 302 participants.
- The trial tested AZD9750 as monotherapy and in combination with saruparib.
- Main goals included safety, tolerability, and a ≥50% decrease in PSA from baseline.
- The trial was completed and was registered in the EU Clinical Trials Information System.
What is AZD9750?
AZD9750 is an investigational chemical substance developed by AstraZeneca AB. It is a small-molecule drug candidate that has not received a marketing authorisation in the product records, which means it is not yet approved as a medicine for routine use. The substance appears under the product name AZD9750 and is classified in the therapeutic area of male urogenital diseases.
How does AZD9750 work?
The available registry data do not describe the molecular target or mechanism of action of AZD9750. The trial record focuses on safety, tolerability, and preliminary antitumour efficacy in metastatic castration-resistant prostate cancer (mCRPC), but no details on how the drug acts at the cellular level are provided in the source material.
Which conditions is AZD9750 studied for?
- Metastatic prostate cancer — cancer of the prostate that has spread to other parts of the body. The trial specifically included participants with metastatic castration-resistant prostate cancer (mCRPC), a form that continues to progress despite lowering testosterone to very low levels.
How is AZD9750 given?
AZD9750 is given as a film-coated tablet by mouth (oral route of administration). In the trial, AZD9750 was administered orally, either alone or together with saruparib, another oral anticancer drug.
What do the clinical trials show?
One completed Phase 1/2 trial (EU CT number 2024-516976-14-00) evaluated AZD9750 in 302 participants with metastatic prostate cancer. The study had two parts. Part A assessed safety and tolerability and aimed to determine the maximum tolerated dose (MTD) and/or the recommended dose(s) for expansion or Phase 2 (RDE/RP2D) of AZD9750 as monotherapy and in combination with other anticancer agents. Part B evaluated preliminary antitumour efficacy of AZD9750 as monotherapy and in combination with other anticancer agents in participants with mCRPC.
The primary outcome measures included the incidence of dose-limiting toxicities (DLTs), adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation of study intervention. Researchers also looked at clinically significant changes from baseline in vital signs, physical examination, ECOG performance status (a measure of how well a person can carry out daily activities), electrocardiograms (ECGs), and laboratory parameters. In Part B, the efficacy measure was the proportion of participants achieving a ≥50% decrease in prostate-specific antigen (PSA) from baseline.
The trial was interventional and has been completed. The study tested AZD9750 as monotherapy and in combination with saruparib, which served as the other anticancer agent in the combination arm.
What side effects are known?
The source data do not provide a list of side effects for AZD9750. The trial measured adverse events, serious adverse events, and dose-limiting toxicities as primary outcomes, but the specific side effects observed were not reported in the registry record.