AZD6621 for Prostate Cancer
(ACTIVATED-4-PC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an experimental treatment called AZD6621 for men with advanced prostate cancer that has spread and is resistant to standard hormone treatments. Researchers aim to determine the safety and effectiveness of AZD6621 by testing different doses and administration methods. Suitable candidates for this trial have prostate cancer that has spread, continues to grow despite hormone therapy, and shows signs of progression, such as increasing PSA levels (a protein related to prostate cancer). As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that participants must not have received certain anti-cancer therapies or systemic corticosteroids above a certain dose shortly before starting the trial. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that AZD6621 is likely to be safe for humans?
Research shows that AZD6621 is a new treatment being tested for safety and side effects in people with advanced prostate cancer. As this is the first human trial, detailed safety information from previous human studies is unavailable. Researchers are still learning about its tolerability and potential side effects.
In this early-stage study, the focus is on testing different doses to determine which are safe. Early studies typically aim to find the optimal dose that balances effectiveness with minimal side effects. Participants might experience some side effects as researchers work to identify the right dose.
Prospective participants should know that researchers closely monitor participants to ensure safety and manage any side effects that arise.12345Why do researchers think this study treatment might be promising for prostate cancer?
Researchers are excited about AZD6621 for prostate cancer because it offers a fresh approach compared to standard treatments like hormone therapy, chemotherapy, and surgery. Unlike these traditional methods, AZD6621 is designed to be a monotherapy with two different administration routes, which could provide flexibility in how it's given to patients. This treatment stands out by potentially targeting cancer cells more directly, reducing the impact on healthy cells and minimizing side effects. Its unique mechanism and delivery methods hold promise for improved outcomes and quality of life for patients with prostate cancer.
What evidence suggests that AZD6621 might be an effective treatment for metastatic prostate cancer?
Research shows that AZD6621 is designed to treat advanced prostate cancer that has spread to other parts of the body. This treatment activates T cells, part of the immune system, to attack cancer cells. Early studies suggest that AZD6621 could be promising due to its potential for greater effectiveness with fewer side effects. Although limited information exists on its efficacy in humans, using T cells to target cancer cells remains a hopeful approach. Ongoing research aims to confirm these early results. Participants in this trial will receive AZD6621 through various administration routes and dosages to evaluate its safety and effectiveness.14678
Are You a Good Fit for This Trial?
This clinical trial is for adult males with metastatic prostate cancer. It's designed to find out how safe and effective a new treatment called AZD6621 is, and how it behaves in the body over time. Participants will be given different doses of AZD6621 to determine the best balance between safety and side effects.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Part A tests different dose levels of AZD6621 to determine the best doses in terms of safety and side effects
Dose Expansion
Part B tests at least two AZD6621 doses in a larger group of participants
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD6621
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology