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AZD0516

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.

Table of contents

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.[1]

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.[1]

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.[1]

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.[1]

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.[1]

AZD0516 is being tested both as monotherapy, meaning by itself, and in combination with other anti-cancer treatments.[1]

Who can join

The trial is for adults with metastatic prostate cancer.[1]

This means the study is focused on people whose prostate cancer has already spread, rather than people with early-stage disease.[1]

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.[1]

Researchers also check whether people stop AZD0516 because of toxicity, which means harmful side effects that make treatment hard to continue.[1]

Other safety checks include changes in laboratory tests, vital signs, ECG results, ECOG performance status, and physical examination findings.[1]

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%.[1]

Trial status and size

The listed trial is currently Authorised.[1]

The planned enrollment is 401 participants, which shows that this is a relatively large early-phase study.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT07181161Phase 1/2Metastatic Prostate CancerAuthorised401

FAQ

  • What is being studied in AZD0516 trials? The trials are studying the safety, tolerability, and early anti-cancer activity of AZD0516. They also look at the best dose to use, both by itself and with other anti-cancer treatments.
  • Who can take part in these trials? The trial listed is for adults with metastatic prostate cancer. This means the cancer has spread beyond the original place where it started.
  • What phase is the AZD0516 trial in? The trial is in Phase 1/2. Phase 1/2 studies usually check safety first and then look for early signs that the treatment may help.
  • What results are the researchers measuring? They are measuring side effects, dose-limiting toxicity, changes in lab tests and vital signs, and early cancer response. One key cancer response measure is PSA50 response rate.
  • Is AZD0516 being tested alone or with other treatments? It is being tested both as a single treatment and together with other anti-cancer agents. The trial is designed to compare these approaches during different parts of the study.

Ongoing Clinical Trials on AZD0516

  • A study testing the safety and effectiveness of AZD0516 alone and with other cancer drugs in adults with metastatic prostate cancer

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Italy Poland Spain

Glossary

  • Metastatic prostate cancer: Prostate cancer that has spread to other parts of the body.
  • Phase 1/2: An early trial stage that first checks safety and dose, then looks for early signs of benefit.
  • Interventional study: A study where researchers give a treatment and observe what happens.
  • Monotherapy: Treatment using one drug alone.
  • Combination treatment: Treatment that uses AZD0516 together with other anti-cancer medicines.
  • Safety: How well a treatment is tolerated and whether it causes harmful effects.
  • Tolerability: How easy or difficult it is for people to stay on a treatment.
  • Dose escalation: A study step where the treatment dose is slowly increased to find a safe level.
  • Dose optimisation: A study step that helps find the dose most likely to work well with acceptable safety.
  • Dose-limiting toxicity: A side effect serious enough to limit how much treatment can be given.
  • PSA50 response rate: The percentage of patients whose prostate-specific antigen, or PSA, level drops by at least 50%.
  • ECOG performance status: A score that shows how well a person can do daily activities.

References