RecruitingPhase 1Phase 2NCT07192614

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


Sponsor

AstraZeneca

Enrollment

52 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called AZD6621 to evaluate its safety, effectiveness, and how the body processes it in men with metastatic prostate cancer that has stopped responding to hormone therapy (called castration-resistant prostate cancer). **You may be eligible if...** - You are a male aged 18 or older - You have been diagnosed with metastatic prostate cancer that has spread and is no longer controlled by hormone therapy - Your testosterone levels are very low (at or below 50 ng/dL) from surgical or medical castration - Your prostate cancer has progressed despite castrate levels of testosterone - Your general health and organ function meet study requirements **You may NOT be eligible if...** - You have not had prior hormone therapy for prostate cancer - Your organ function (liver, kidneys, blood counts) does not meet required thresholds - You have other conditions that prevent safe study participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD6621

A T Cell-engaging Antibody that targets STEAP2, CD3, and CD8


Locations(18)

Research Site

Orlando, Florida, United States

Research Site

Tampa, Florida, United States

Research Site

Boston, Massachusetts, United States

Research Site

Grand Rapids, Michigan, United States

Research Site

Commack, New York, United States

Research Site

Providence, Rhode Island, United States

Research Site

Ghent, Belgium

Research Site

Beijing, China

Research Site

Guangzhou, China

Research Site

Nanjing, China

Research Site

Chūōku, Japan

Research Site

Hirakata-shi, Japan

Research Site

Kashiwa, Japan

Research Site

Amsterdam, Netherlands

Research Site

Maastricht, Netherlands

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Cambridge, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07192614


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