A Study of AZD6621 for Metastatic Prostate Cancer
This study is looking into a new treatment called AZD6621 for men with metastatic prostate cancer (cancer that has spread to other parts of the body). AZD6621 is a special type of antibody that targets specific proteins (STEAP2, CD3, and CD8) to help your body's immune system fight the cancer. The main goals are to see how safe AZD6621 is, what side effects it might cause, and how well it works against the cancer. The study will also track how the drug moves through your body over time. It's open to adult men aged 18 and older who have been diagnosed with metastatic prostate cancer. The study is currently unclear on its recruitment status.
- Study design
- This is a Phase I/II, open-label study, meaning both you and the study team will know which treatment you are receiving. It plans to enroll 52 participants and will test different doses of AZD6621.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for adverse events for up to 90 days after your last dose of AZD6621, which could be up to 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer
At a glance
Conditions
Where it's being run
26 sites across 14 statesWho to contact
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What this trial measures
- Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE)From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years)
• Number of participants with AEs, AESIs, SAEs, including AEs leading to discontinuation of study intervention and clinically significant alterations from baseline in laboratory parameters, vital signs, ECGs and physical examination results
- Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)From first study dose to 21 to 28 days post first dose
• A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.
- Preliminary anti-tumour activity of AZD6621 (PSA Response Rate) (Part B only)Up to 3 years
• Number of participants with a PSA response rate