RecruitingPhase 1NCT04221542

Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Sponsor

Amgen

Enrollment

479 participants

Start Date

Mar 4, 2020

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

The overall aim of the trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of AMG 509 (monotherapy and in combination with abiraterone acetate and enzalutamide) and to evaluate preliminary efficacy. As of Protocol Amendment 10 (09 July 2025), only Parts 4A expansion, 6, and 7 are open to accrual.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AMG 509 in men with advanced prostate cancer that has spread (metastatic) and no longer responds to hormone-blocking treatments (castration-resistant). It is an early-phase study looking at safety and effectiveness. **You may be eligible if...** - You are a man with prostate cancer that has spread to other parts of the body - Your cancer no longer responds to hormone-blocking treatments (like abiraterone or enzalutamide) - You have already received at least one, but not more than two, taxane-based chemotherapy regimens - You are in reasonable overall health **You may NOT be eligible if...** - You have received more than two different hormonal therapies or more than two taxane chemotherapy regimens - You have not received any prior treatment - You have serious uncontrolled health conditions - You are unable to give informed consent 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

DRUGAMG 509

AMG 509 administered as an IV infusion (Parts 1, 3, 4 and 5) or SC injection (Part 2).

DRUGAbiraterone

Abiraterone administered as oral tablets.

DRUGEnzalutamide

Enzalutamide administered as oral tablets.

Locations(57)

City of Hope National Medical Center

Duarte, California, United States

Providence Saint Jude Medical Center

Fullerton, California, United States

University of California San Francisco

San Francisco, California, United States

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Emory University

Atlanta, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

MidAmerica Cancer Care

Merriam, Kansas, United States

Tulane Medical Center

New Orleans, Louisiana, United States

Washington University

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University

Durham, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Oncology Hematology Care Incorporated

Cincinnati, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Prisma Health Upstate

Greenville, South Carolina, United States

Sanford Oncology Clinic and Pharmacy

Sioux Falls, South Dakota, United States

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

US Oncology Research Investigational Products Center

Irving, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Virginia Cancer Specialists PC

Fairfax, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Peking University First Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Fudan University Shanghai Cancer Centre

Shanghai, Shanghai Municipality, China

Zhejiang Provincial Peoples Hospital

Hangzhou, Zhejiang, China

Nanjing Drum Tower Hospital

Nanjing, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Universitaetsklinikum Essen

Essen, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Klinikum rechts der Isar der TUM

München, Germany

Universitaetsklinikum Muenster

Münster, Germany

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan

Hospital da Luz, SA

Lisbon, Portugal

Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, Portugal

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

Porto, Portugal

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, Spain

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Istituto Oncologico della Svizzera Italiana

Bellinzona, Switzerland

Kantonsspital Graubuenden

Chur, Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Kantonsspital Sankt Gallen

Sankt Gallen, Switzerland

National Taiwan University Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

Taoyuan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT04221542

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