RecruitingPhase 1NCT05519449

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Sponsor

Janux Therapeutics

Enrollment

272 participants

Start Date

Sep 15, 2022

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Metastatic Castration-resistant Prostate Cancer

Summary

This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called JANX007 — a bispecific antibody that helps the immune system attack prostate cancer — in men with metastatic castration-resistant prostate cancer (prostate cancer that has spread and no longer responds to hormone therapy). **You may be eligible if...** - You are a male 18 years or older - You have prostate cancer confirmed by biopsy - Your cancer has spread and no longer responds to hormone therapy - You have received prior treatment with at least one hormone-blocking drug and one taxane chemotherapy (or have refused/are unsuitable for taxane) - Your organ function is adequate **You may NOT be eligible if...** - You have had a prior solid organ transplant - You have previously received CAR-T cell therapy targeting PSMA, or certain other PSMA-targeted treatments - Your overall health does not meet the study requirements 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

BIOLOGICALJANX007

JANX007 is dosed via IV in a 21- or 28-day cycle.

DRUGDarolutamide

Darolutamide is dosed via oral tablets

Locations(35)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, United States

Mayo Clinic

Phoenix, Arizona, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCLA Department of Medicine

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Mayo Clinic

Jacksonville, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Northwell Health R.J. Zuckerberg Cancer Hospital

Lake Success, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Thomas Jefferson University Honickman Center

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Sarah Cannon Research

Nashville, Tennessee, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Chris O'Brien Lifehouse (COBLH)

Camperdown, New South Wales, Australia

Southern Oncology Clinical Research Unit (SoCRU)

Bedford Park, South Australia, Australia

Linear Clinical Research Ltd.

Nedlands, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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