NCT07529717

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2026-04-09
• Primary completion: 2027-10-11
• Completion: 2027-10-11
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

8 sites across 3 countries: United States, Australia, South Korea

Regulatory

• FDA-regulated drug study