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Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
NCT05519449 · Janux Therapeutics
In plain English
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Official title
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer
About this study
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
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
Study design
Enrollment target: 272 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-09-15
Estimated completion: 2028-12
Last updated: 2026-01-20
Interventions
Biological: JANX007Drug: Darolutamide
Primary outcomes
- • Incidence of Dose Limiting Toxicities (DLT) (3 years)
- • Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) (3 years)
Sponsor
Janux Therapeutics · industry
Contacts & investigators
ContactJanux Therapeutics · contact · psma-007-001_ct.gov@januxrx.com · 858-206-8471
InvestigatorJanux Therapeutics, MD · study_director, Janux Therapeutics
All locations (35)
University of Alabama at Birmingham HospitalRecruiting
Birmingham, Alabama, United States
Mayo ClinicRecruiting
Phoenix, Arizona, United States
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
UCLA Department of MedicineRecruiting
Los Angeles, California, United States
Hoag Memorial Hospital PresbyterianRecruiting
Newport Beach, California, United States
University of California Davis Comprehensive Cancer CenterRecruiting
Sacramento, California, United States
UCSF Helen Diller Family Comprehensive Cancer CenterRecruiting
San Francisco, California, United States
Yale New Haven HospitalRecruiting
New Haven, Connecticut, United States
Mayo ClinicRecruiting
Jacksonville, Florida, United States
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
University of Maryland Greenebaum Comprehensive Cancer CenterRecruiting
Baltimore, Maryland, United States
Massachusetts General HospitalActive Not Recruiting
Boston, Massachusetts, United States
University of Minnesota Medical CenterRecruiting
Minneapolis, Minnesota, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Northwell Health R.J. Zuckerberg Cancer HospitalRecruiting
Lake Success, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Weill Cornell MedicineRecruiting
New York, New York, United States
Montefiore Medical CenterRecruiting
The Bronx, New York, United States
University of Cincinnati Medical CenterRecruiting
Cincinnati, Ohio, United States
Oregon Health and Science UniversityActive Not Recruiting
Portland, Oregon, United States
Penn State Milton S. Hershey Medical CenterRecruiting
Hershey, Pennsylvania, United States
Thomas Jefferson University Honickman CenterRecruiting
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
Rhode Island HospitalRecruiting
Providence, Rhode Island, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Sarah Cannon ResearchRecruiting
Nashville, Tennessee, United States
Mary Crowley Cancer ResearchRecruiting
Dallas, Texas, United States
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Houston Methodist HospitalRecruiting
Houston, Texas, United States
University of Wisconsin Carbone Cancer CenterRecruiting
Madison, Wisconsin, United States
Froedtert Hospital and the Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Chris O'Brien Lifehouse (COBLH)Recruiting
Camperdown, New South Wales, Australia
Southern Oncology Clinical Research Unit (SoCRU)Recruiting
Bedford Park, South Australia, Australia
Linear Clinical Research Ltd.Recruiting
Nedlands, Western Australia, Australia