A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer
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).
Arms & interventions
- BiologicalJANX007
JANX007 is dosed via IV in a 21- or 28-day cycle.
- DrugDarolutamide
Darolutamide is dosed via oral tablets
Outcome measures
Primary
Incidence of Dose Limiting Toxicities (DLT)
Time frame: 3 years
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: 3 years
Secondary
Area under the concentration time curve to infinity of JANX007 (AUC0-inf)
Time frame: 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)
Time frame: 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
Time frame: Up to 3 years
Duration of Response
Time frame: Up to 3 years
Prostate Specific Antigen (PSA) response
Time frame: Up to 3 years
Radiographic Progression Free Survival (rPFS)
Time frame: Up to 3 years
Overall Response Rate
Time frame: Up to 3 years
Overall Survival
Time frame: Up to 3 years
Eligibility criteria
Study locations (32)
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35249
Mayo Clinic
Phoenix, Arizona, 85054
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UCLA Department of Medicine
Los Angeles, California, 90095
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
Yale New Haven Hospital
New Haven, Connecticut, 06510
Mayo Clinic
Jacksonville, Florida, 32224
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Mayo Clinic
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
Northwell Health R.J. Zuckerberg Cancer Hospital
Lake Success, New York, 11042
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medicine
New York, New York, 10065
Montefiore Medical Center
The Bronx, New York, 10461
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Oregon Health and Science University
Portland, Oregon, 97239
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Thomas Jefferson University Honickman Center
Philadelphia, Pennsylvania, 19107
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Rhode Island Hospital
Providence, Rhode Island, 02903
Medical University of South Carolina
Charleston, South Carolina, 29425
Sarah Cannon Research
Nashville, Tennessee, 37203
Mary Crowley Cancer Research
Dallas, Texas, 75230
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Houston Methodist Hospital
Houston, Texas, 77030
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226