First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer
Start Date
5/18/2026
Completion Date
11/17/2027
Summary
This study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic prostate cancer called AZD8359. The study is split into different modules which will look at AZD8359 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels and dosing schedules of AZD8359 to determine which doses are the best in terms of safety and side effects (dose escalation), and Part B will further test at least two AZD8359 doses in a larger group of participants (dose expansion).
Detailed Description
This is a first-in-human, modular, Phase I/II, open label, multicenter study of AZD8359, in adult participants with metastatic prostate cancer. The study will consist of study modules, each evaluating the the safety, tolerability, preliminary efficacy, immune cell activation and anti-tumor activity of AZD8359. The study will also characterize the pharmacokinetics and immunogenicity of AZD8359.
Eligibility Criteria
Age Range: 18 years to 100 years
Interventions
AZD8359
AZD8359
AZD8359
AZD8359
Conditions
Locations
Research Site
Orlando, Florida 32806
United States
Research Site
East Brunswick, New Jersey 08816
United States
Research Site
Hackensack, New Jersey 07601
United States
Research Site
Providence, Rhode Island 02903
United States
Research Site
Darlinghurst, 2010
Australia
Research Site
Melbourne, 3000
Australia
Research Site
Seoul, 03722
South Korea
Research Site
Seoul, 06351
South Korea