In short
AZD6621 is an investigational medicine being studied for metastatic prostate cancer. It is given by intravenous infusion. One registered clinical trial, NCT07192614, is currently authorised and plans to enrol 171 adult male participants in a Phase 1/2 study to assess safety, tolerability, and early anti-tumour activity.
Key points
- AZD6621 is an investigational medicine studied in metastatic prostate cancer.
- The registered trial is Phase 1/2 and is currently authorised.
- The study plans to enrol 171 adult male participants.
- AZD6621 is given by intravenous infusion.
- The trial measures safety, tolerability, dose-limiting toxicities, and PSA response rate.
What is AZD6621?
AZD6621 is an investigational medicine being developed for the treatment of metastatic prostate cancer. It is not yet an authorised medicine; it is being evaluated in clinical trials to learn about its safety and effects in people. The trial record describes AZD6621 as a drug given by intravenous use.
How does AZD6621 work?
The registered trial data do not describe the mechanism of action of AZD6621. The study is designed to assess how safe the medicine is, how well it works, and how it moves throughout the body over time in adult male participants with metastatic prostate cancer. The trial will characterise dose-limiting toxicities and determine the maximum tolerated dose and recommended dose for expansion.
Which conditions is AZD6621 studied for?
- Metastatic prostate cancer — a form of prostate cancer that has spread to other parts of the body. The trial enrols adult male participants with this condition.
How is AZD6621 given?
AZD6621 is given by intravenous use, meaning it is administered directly into a vein. The trial record does not provide further details on the pharmaceutical form, such as whether it is a solution for infusion or another intravenous formulation.
What do the clinical trials show?
One clinical trial of AZD6621 is registered. It is a Phase 1/2 interventional study that is currently authorised. The trial plans to enrol 171 adult male participants with metastatic prostate cancer.
The study is divided into two parts. Part A assesses the safety and tolerability of AZD6621, characterises dose-limiting toxicities, and determines the maximum tolerated dose and recommended dose for expansion, as monotherapy or in combination. Part B, the dose expansion or optimisation part, assesses the preliminary anti-tumour activity of AZD6621 as monotherapy or in combination.
The primary outcomes measured in this trial include the incidence of adverse events, adverse events of special interest, dose-limiting toxicities, and serious adverse events; the rate of AZD6621 discontinuation due to toxicity; changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination; and, in Part B only, the PSA response rate. PSA stands for prostate-specific antigen, a protein produced by the prostate that is measured to assess prostate cancer activity.
What side effects are known?
The known side effects of AZD6621 have not yet been published in the registered trial data. The clinical trial is designed to measure the incidence of adverse events, adverse events of special interest, dose-limiting toxicities, and serious adverse events, which will provide information on side effects.