In short
Clinical trials are investigating AZD0516 in adults with metastatic prostate cancer. These studies aim to learn how safe AZD0516 is, how well it works, and which dose may be best, both alone and with other cancer treatments. The main trial is in a phase 1/2 setting.
Key points
- Clinical trials of AZD0516 are studying adults with metastatic prostate cancer. The main trial is a Phase 1/2 study, which means it first checks safety and dose, then looks for early signs of benefit. Researchers are testing AZD0516 both alone and with other anti-cancer treatments. They are measuring side effects, dose-limiting toxicity, lab and vital sign changes, and early cancer response such as PSA50 response rate. The listed study is authorised and plans to enroll 401 people. The trial is designed in parts for dose escalation, dose optimisation, and efficacy expansion.
Trial overview
AZD0516 is being studied in an interventional clinical trial for adults with metastatic prostate cancer, which means prostate cancer that has spread to other parts of the body.
The listed trial is a Phase 1/2 study, so it is designed to learn about safety first and then look for early signs that the treatment may help.
Study parts and treatment plan
The study has several parts: dose escalation in Part A, dose optimisation in Part B, and efficacy expansion in Part C.
In Part A, researchers are checking safety and trying to find the maximum tolerated dose and/or the recommended dose of AZD0516 when used alone and with anti-cancer agents.
In Parts B and C, the study looks at early anti-tumour activity, which means whether the treatment shows signs of helping against the cancer.
AZD0516 is being tested both as monotherapy, meaning by itself, and in combination with other anti-cancer treatments.
Who can join
The trial is for adults with metastatic prostate cancer.
This means the study is focused on people whose prostate cancer has already spread, rather than people with early-stage disease.
What researchers measure
The main safety measures include the number of adverse events, serious adverse events, and adverse events of special interest, as well as dose-limiting toxicities.
Researchers also check whether people stop AZD0516 because of toxicity, which means harmful side effects that make treatment hard to continue.
Other safety checks include changes in laboratory tests, vital signs, ECG results, ECOG performance status, and physical examination findings.
For early efficacy, one key measure is the PSA50 response rate, which means the share of patients whose PSA level drops by at least 50%.
Trial status and size
The listed trial is currently Authorised.
The planned enrollment is 401 participants, which shows that this is a relatively large early-phase study.