Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
NCT ID: NCT05519449
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
272 participants
INTERVENTIONAL
2022-09-15
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
IV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose.
JANX007
JANX007 is dosed via IV in a 21- or 28-day cycle.
Backfill Expansion
IV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable.
JANX007
JANX007 is dosed via IV in a 21- or 28-day cycle.
Monotherapy Expansion Parts A - D
IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).
JANX007
JANX007 is dosed via IV in a 21- or 28-day cycle.
Combination Expansion
IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose
JANX007
JANX007 is dosed via IV in a 21- or 28-day cycle.
Darolutamide
Darolutamide is dosed via oral tablets
Interventions
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JANX007
JANX007 is dosed via IV in a 21- or 28-day cycle.
Darolutamide
Darolutamide is dosed via oral tablets
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
100 Years
MALE
No
Sponsors
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Janux Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Janux Therapeutics, MD
Role: STUDY_DIRECTOR
Janux Therapeutics
Locations
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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
Massachusetts General Hospital
Boston, Massachusetts, 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
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
Oregon Health and Science University
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, 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
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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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ENGAGER-PSMA-01
Identifier Type: OTHER
Identifier Source: secondary_id
PSMA-007-001
Identifier Type: -
Identifier Source: org_study_id