RecruitingPhase 1Phase 2NCT07181161

Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Metastatic Prostate Cancer

Sponsor

AstraZeneca

Enrollment

177 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Prostate Cancer

Summary

The main purpose of this study is to assess the safety and tolerability of AZD0516 as monotherapy and/or in combination with other anti-cancer agents for treatment of metastatic prostate cancer.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AZD0516, either alone or in combination with other treatments, in men with prostate cancer that has spread and is no longer responding to hormone therapy (castration-resistant prostate cancer). **You may be eligible if...** - You are 18 or older - You have been diagnosed with metastatic prostate adenocarcinoma (the most common type) - Your testosterone levels are very low (castrate levels) from surgery or ongoing hormone-blocking treatment - Your cancer is measurable by PSA levels (at least 1 ng/mL) - Your general health and organ function are within acceptable range (ECOG 0-1) **You may NOT be eligible if...** - You have purely neuroendocrine or small cell prostate cancer - You have uncontrolled serious medical conditions - You are unable to maintain castrate testosterone levels - You are on blood thinners or medications that conflict with the study drug 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

DRUGAZD0516

AZD0516 will be administered via intravenous infusion.

DRUGAZD9574

AZD9574 will be administered orally.

Locations(51)

Research Site

Fayetteville, Arkansas, United States

Research Site

Los Angeles, California, United States

Research Site

Boston, Massachusetts, United States

Research Site

Ann Arbor, Michigan, United States

Research Site

Detroit, Michigan, United States

Research Site

Buffalo, New York, United States

Research Site

New York, New York, United States

Research Site

Providence, Rhode Island, United States

Research Site

Myrtle Beach, South Carolina, United States

Research Site

Houston, Texas, United States

Research Site

Barretos, Brazil

Research Site

Porto Alegre, Brazil

Research Site

São Paulo, Brazil

Research Site

Changsha, China

Research Site

Chengdu, China

Research Site

Wuhan, China

Research Site

Lyon, France

Research Site

Montpellier, France

Research Site

Saint-Herblain, France

Research Site

Suresnes, France

Research Site

Villejuif, France

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Milan, Italy

Research Site

Milan, Italy

Research Site

Milan, Italy

Research Site

Naples, Italy

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Roma, Italy

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Rozzano, Italy

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Chūōku, Japan

Research Site

Kashiwa, Japan

Research Site

Kōtoku, Japan

Research Site

Koszalin, Poland

Research Site

Piotrkow Trybunalski, Poland

Research Site

Przemyśl, Poland

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Barcelona, Spain

Research Site

Barcelona, Spain

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Barcelona, Spain

Research Site

L'Hospitalet de Llobregat, Spain

Research Site

Madrid, Spain

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Pamplona, Spain

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Santander, Spain

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Valencia, Spain

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Cambridge, United Kingdom

Research Site

London, United Kingdom

Research Site

London, United Kingdom

Research Site

Plymouth, United Kingdom

Research Site

Sutton, United Kingdom

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NCT07181161

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