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NCT05519449PHASE1Recruiting

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

Janux Therapeutics

Start Date

9/15/2022

Completion Date

12/1/2028

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 Criteria

Age Range: 18 years to 100 years

Inclusion Criteria: * Male ≥18 years of age at the time of signing informed consent * Histologically or cytologically confirmed adenocarcinoma of the prostate * For Dose Escalation and Backfill: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible * Adequate organ function * For Monotherapy Expansion Part a: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC or CRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible. * For Monotherapy Expansion Part b: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC settings * For Monotherapy Expansion Part d: Have received ≤ 1 anti-androgen therapy and a poly(ADP-ribose) polymerase (PARP) inhibitor for mCRPC and have progressed following treatment with the PARP inhibitor * For Combination Expansion: Have received ≤ 1 anti-androgen therapy other than darolutamide in the HSPC setting and ≤ 1 taxane in the mCRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible. Exclusion Criteria: * Prior solid organ transplant * Prior treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy * Clinically significant cardiovascular disease * For Monotherapy Expansion Part a: Prior receipt of any treatment other than an ARPI or taxane in the mCRPC setting * For Monotherapy Expansion Part b: Prior receipt of any treatment other than an anti-androgen therapy or prior receipt of a taxane containing regimen or more than 1 prior line of therapy for mCRPC * For Monotherapy Part d: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than an anti-androgen therapy and PARP inhibitor for mCRPC or prior receipt of a taxane in the mCRPC setting * For Combination expansion: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than a taxane for mCRPC or prior receipt of Darolutamide or prior receipt of a taxane for HSPC * Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other) * Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment

Interventions

BIOLOGICAL

JANX007

DRUG

Darolutamide

Interested in This Trial?

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Conditions

Prostate CancerMetastatic Castration-resistant Prostate CancerCastration Resistant Prostatic Cancer

Locations

University of Alabama at Birmingham Hospital

Birmingham, Alabama 35249

United States

Mayo Clinic

Phoenix, Arizona 85054

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

UCLA Department of Medicine

Los Angeles, California 90095

United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California 92663

United States

University of California Davis Comprehensive Cancer Center

Sacramento, California 95817

United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California 94158

United States

Yale New Haven Hospital

New Haven, Connecticut 06510

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland 21201

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

University of Minnesota Medical Center

Minneapolis, Minnesota 55455

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Northwell Health R.J. Zuckerberg Cancer Hospital

Lake Success, New York 11042

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Weill Cornell Medicine

New York, New York 10065

United States

Montefiore Medical Center

The Bronx, New York 10461

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45267

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania 17033

United States

Thomas Jefferson University Honickman Center

Philadelphia, Pennsylvania 19107

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Sarah Cannon Research

Nashville, Tennessee 37203

United States

Mary Crowley Cancer Research

Dallas, Texas 75230

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin 53792

United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Chris O'Brien Lifehouse (COBLH)

Camperdown, New South Wales 2050

Australia

Southern Oncology Clinical Research Unit (SoCRU)

Bedford Park, South Australia 5042

Australia

Linear Clinical Research Ltd.

Nedlands, Western Australia 6009

Australia