Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Incidence of Dose Limiting Toxicities (DLT) — 3 years
- Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) — 3 years
Trial sites (38)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| Start Madrid - FJD, Hospital Fundacion Jimenez Diaz | Madrid | Spain | Recruiting |
| START Madrid / Centro Integral Oncologico Clara Campal | Madrid | Spain | Recruiting |
More Janux Therapeutics trials in the USA
Other trials for the same condition
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 the USA