Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Recruiting · NCT05519449 · Interventional (participants receive a specific treatment) · Lead sponsor: Janux Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
DarolutamideJANX007
What this trial is about
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).
Who can take part
Age range
18 Years to 100 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
36 locations listed across 17 US states.
- 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
- 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
- NYU Langone Health Long Island - Mineola, New York, United States
- NYU Langone Health - New York, 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
- The Ohio State University - Columbus, Ohio, 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