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First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer
Sponsor: AstraZeneca
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).
Official title: Phase I/II Dose Escalation & Dose Optimization Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD8359, a CD8-guided T Cell-engaging Antibody That Targets STEAP2, in Adult Participants With Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2026-04-09
Completion Date
2027-10-11
Last Updated
2026-04-14
Healthy Volunteers
No
Conditions
Interventions
AZD8359
AZD8359 Monotherapy Administration route 1
AZD8359
AZD8359 Monotherapy Administration route 2
AZD8359
AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1)
AZD8359
AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)
Locations (8)
Research Site
Orlando, Florida, United States
Research Site
East Brunswick, New Jersey, United States
Research Site
Hackensack, New Jersey, United States
Research Site
Providence, Rhode Island, United States
Research Site
Darlinghurst, Australia
Research Site
Melbourne, Australia
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea