NCT07192614

A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer

A Phase I/II Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6621, a T Cell-engaging Antibody That Targets STEAP2, CD3, and CD8 in Adult Participants With Metastatic Prostate Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 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 AZD6621. The study is split into different modules which will look at AZD6621 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels of AZD6621 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 AZD6621 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 AZD6621, in adult participants with metastatic prostate cancer. The study will consist of study modules, each evaluating safety, tolerability, PK, pharmacodynamics, and anti-tumor activity of AZD6621 in metastatic prostate cancer. The study will also characterize the PK and immunogenicity of AZD6621.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	AZD6621	A T Cell-engaging Antibody that targets STEAP2, CD3, and CD8

Timeline

• Start date: 2025-09-30
• Primary completion: 2029-03-29
• Completion: 2029-03-29
• First posted: 2025-09-25
• Last updated: 2026-02-23

Locations

18 sites across 7 countries: United States, Belgium, China, Japan, Netherlands, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study