First-in-Human Study of AZD8359 for Treating Prostate Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07529717
This clinical trial is testing a new treatment called AZD8359 for men with prostate cancer that has spread to other parts of the body. The study aims to find out if the treatment is safe, how well it works, and the best way to give it to patients.
Patient Parameters
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Program Overview
The study is designed to learn about the safety and effectiveness of AZD8359, a new treatment for metastatic prostate cancer. It is divided into two main parts: Part A will test different doses to find the safest and most effective one, while Part B will further test these doses in more patients to see how well they work.
Description
This is the first time AZD8359 is being tested in humans. The study is open to adults with prostate cancer that has spread beyond the prostate. It will take place at multiple centers and will be divided into different modules to evaluate the safety, side effects, and effectiveness of AZD8359. Researchers will also study how the drug moves through the body and how the immune system responds to it.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of prostate cancer.
- Must have low testosterone levels due to surgery or medication.
- PSA levels must be 1 ng/mL or higher at screening.
- Cancer must have shown signs of getting worse in the last 6 months.
- For Part A: Must have tried at least two previous treatments for prostate cancer, including one that targets androgen receptors and one taxane-based treatment if suitable.
- For Part B: Must have tried an androgen receptor pathway inhibitor for metastatic prostate cancer. No previous taxane treatment for certain modules in Part B.
- Must have good organ function.
- Must weigh at least 35 kg (about 77 pounds).
Exclusion Criteria
- Have significant heart problems, like irregular heartbeats or prolonged QT interval.
- Any side effects from previous treatments must have improved to a mild level.
- Have a history of severe reactions to previous treatments, like cytokine release syndrome or neurotoxicity.
- Have had autoimmune or inflammatory disorders in the past 3 years.
- Have previously been treated with any STEAP2 targeted agents or TCEs for prostate cancer.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 32806 | Orlando | Florida |
| Research Site | 08816 | East Brunswick | New Jersey |
| Research Site | 07601 | Hackensack | New Jersey |
| Research Site | 02903 | Providence | Rhode Island |
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