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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
272
JANX007 is dosed via IV in a 21- or 28-day cycle.
Darolutamide is dosed via oral tablets
Incidence of Dose Limiting Toxicities (DLT)
Time frame: 3 years
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: 3 years
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 from documentation of complete response or partial response to disease progression using RECIST v1.1 and PCWG3
Time frame: Up to 3 years
Prostate Specific Antigen (PSA) response
Best reduction in PSA level achieved confirmed by a second PSA test ≥21 days later
Time frame: Up to 3 years
Radiographic Progression Free Survival (rPFS)
Time from treatment initiation to radiographic evidence of disease progression using RECIST v1.1 and PCWG3
Time frame: Up to 3 years
Overall Response Rate
Proportion of participants who achieve a complete response or partial response using RECIST v1.1 and PCWG3
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University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
RECRUITINGMayo Clinic
Phoenix, Arizona, United States
RECRUITINGUSC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGUCLA Department of Medicine
Los Angeles, California, United States
RECRUITINGHoag Memorial Hospital Presbyterian
Newport Beach, California, United States
RECRUITINGUniversity of California Davis Comprehensive Cancer Center
Sacramento, California, United States
RECRUITINGUCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
RECRUITINGYale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGMayo Clinic
Jacksonville, Florida, United States
RECRUITINGUniversity of Chicago Medical Center
Chicago, Illinois, United States
RECRUITING...and 25 more locations
Time frame: Up to 3 years
Overall Survival
Time from treatment initiation until death from any cause
Time frame: Up to 3 years