Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer
2 other identifiers
interventional
272
2 countries
35
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 prostate-cancer
Started Sep 2022
Longer than P75 for phase_1 prostate-cancer
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2022
CompletedFirst Posted
Study publicly available on registry
August 29, 2022
CompletedStudy Start
First participant enrolled
September 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
January 20, 2026
July 1, 2025
4.8 years
August 25, 2022
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Dose Limiting Toxicities (DLT)
3 years
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
3 years
Secondary Outcomes (8)
Area under the concentration time curve to infinity of JANX007 (AUC0-inf)
Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years)
Maximum observed concentration of JANX007 (Cmax)
Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years)
Number of participants who develop anti-drug antibodies against JANX007
Up to 3 years
Duration of Response
Up to 3 years
Prostate Specific Antigen (PSA) response
Up to 3 years
- +3 more secondary outcomes
Study Arms (4)
Dose Escalation
EXPERIMENTALIV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose.
Backfill Expansion
EXPERIMENTALIV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable.
Monotherapy Expansion Parts A - D
EXPERIMENTALIV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).
Combination Expansion
EXPERIMENTALIV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose
Interventions
JANX007 is dosed via IV in a 21- or 28-day cycle.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35249, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UCLA Department of Medicine
Los Angeles, California, 90095, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Northwell Health R.J. Zuckerberg Cancer Hospital
Lake Success, New York, 11042, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University Honickman Center
Philadelphia, Pennsylvania, 19107, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Sarah Cannon Research
Nashville, Tennessee, 37203, United States
Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Chris O'Brien Lifehouse (COBLH)
Camperdown, New South Wales, 2050, Australia
Southern Oncology Clinical Research Unit (SoCRU)
Bedford Park, South Australia, 5042, Australia
Linear Clinical Research Ltd.
Nedlands, Western Australia, 6009, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janux Therapeutics, MD
Janux Therapeutics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2022
First Posted
August 29, 2022
Study Start
September 15, 2022
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
January 20, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share