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NOT YET RECRUITING
NCT07529717
PHASE1/PHASE2

First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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

Interventions

DRUG

AZD8359

AZD8359 Monotherapy Administration route 1

DRUG

AZD8359

AZD8359 Monotherapy Administration route 2

DRUG

AZD8359

AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1)

DRUG

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