Actively Recruiting
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Led by Janux Therapeutics · Updated on 2026-01-20
272
Participants Needed
35
Research Sites
324 weeks
Total Duration
On this page
AI-Summary
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).
CONDITIONS
Official Title
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male 18 years of age or older at the time of signing informed consent
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- For Dose Escalation and Backfill: mCRPC progressed after at least one novel anti-androgen therapy and one taxane regimen, or taxane refusal or medical unsuitability
- Adequate organ function
- For Monotherapy Expansion Part a: Received 2 or fewer anti-androgen therapies and no more than 1 prior taxane regimen; taxane refusal or unsuitability allowed
- For Monotherapy Expansion Part b: Received 2 or fewer anti-androgen therapies
- For Monotherapy Expansion Part d: Received 1 or fewer anti-androgen therapy and a PARP inhibitor for mCRPC and progressed after PARP inhibitor
- For Combination Expansion: Received 1 or fewer anti-androgen therapy (other than darolutamide) in HSPC and 1 or fewer taxane in mCRPC; taxane refusal or unsuitability allowed
You will not qualify if you...
- Prior solid organ transplant
- Prior treatment with PSMA-targeted CAR-T, 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 treatment other than ARPI or taxane in mCRPC
- For Monotherapy Expansion Part b: Prior treatment other than anti-androgen therapy or prior taxane regimen or more than 1 prior mCRPC therapy line
- For Monotherapy Part d: More than 1 prior mCRPC therapy line or prior treatment other than anti-androgen and PARP inhibitor or prior taxane in mCRPC
- For Combination expansion: More than 1 prior mCRPC therapy line or prior treatment other than taxane or prior darolutamide or prior taxane for HSPC
- Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)
- Any medical condition or lab abnormality likely to interfere with safety or efficacy assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States, 35249
Actively Recruiting
2
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
UCLA Department of Medicine
Los Angeles, California, United States, 90095
Actively Recruiting
5
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
6
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
7
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
8
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
9
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
10
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
11
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
12
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Active, Not Recruiting
13
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
14
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
15
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
16
Northwell Health R.J. Zuckerberg Cancer Hospital
Lake Success, New York, United States, 11042
Actively Recruiting
17
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
18
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
19
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
20
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
21
Oregon Health and Science University
Portland, Oregon, United States, 97239
Active, Not Recruiting
22
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
23
Thomas Jefferson University Honickman Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
24
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
25
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
26
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
27
Sarah Cannon Research
Nashville, Tennessee, United States, 37203
Actively Recruiting
28
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Actively Recruiting
29
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
30
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
31
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
32
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
33
Chris O'Brien Lifehouse (COBLH)
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
34
Southern Oncology Clinical Research Unit (SoCRU)
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
35
Linear Clinical Research Ltd.
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
J
Janux Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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