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Clinical Trials in Australia / NCT05519449
Recruiting Phase 1

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

NCT05519449 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2022-09-15
Last updated
2026-08-13

Condition(s) studied

Prostate CancerMetastatic Castration-resistant Prostate CancerCastration Resistant Prostatic Cancer

Investigational drug(s) / intervention(s)

JANX007 →Darolutamide →

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

Darolutamide: Darolutamide is dosed via oral tablets

Study 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
MALE
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
University of Alabama at Birmingham Hospital Birmingham Alabama Recruiting
Mayo Clinic Phoenix Arizona Recruiting
USC Norris Comprehensive Cancer Center Los Angeles California Recruiting
UCLA Department of Medicine Los Angeles California Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California Recruiting
University of California Davis Comprehensive Cancer Center Sacramento California Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California Recruiting
Yale New Haven Hospital New Haven Connecticut Recruiting
Mayo Clinic Jacksonville Florida Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
University of Maryland Greenebaum Comprehensive Cancer Center Baltimore Maryland Recruiting
University of Minnesota Medical Center Minneapolis Minnesota Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Northwell Health R.J. Zuckerberg Cancer Hospital Lake Success New York Recruiting
NYU Langone Health Long Island Mineola New York Recruiting
NYU Langone Health New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Weill Cornell Medicine New York New York Recruiting
Montefiore Medical Center The Bronx New York Recruiting
University of Cincinnati Medical Center Cincinnati Ohio Recruiting
The Ohio State University Columbus Ohio Recruiting
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania Recruiting
Thomas Jefferson University Honickman Center Philadelphia Pennsylvania Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
Rhode Island Hospital Providence Rhode Island Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
Sarah Cannon Research Nashville Tennessee Recruiting
Mary Crowley Cancer Research Dallas Texas Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
Houston Methodist Hospital Houston Texas Recruiting
University of Wisconsin Carbone Cancer Center Madison Wisconsin Recruiting
Froedtert Hospital and the Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Chris O'Brien Lifehouse (COBLH) Camperdown New South Wales Recruiting
Southern Oncology Clinical Research Unit (SoCRU) Bedford Park South Australia Recruiting
Linear Clinical Research Ltd. Nedlands Western Australia Recruiting

More Janux Therapeutics trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05519449 on ClinicalTrials.gov ↗ ← All trials in Australia