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 JANX013 in combination with JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Sarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGIncidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Time frame: 2 years
Incidence of cytokine release syndrome (CRS)
Cytokine release syndrome (CRS) assessed according to ASTCT criteria.
Time frame: 2 years
Area under the curve from 0 to t of JANX013 and JANX007
Time frame: Up to 2 years
Maximum observed concentration of JANX013 and JANX007
Time frame: Up to 2 years
Time to maximum concentration of JANX013 and JANX007
Time frame: Up to 2 years
Number of participants who develop anti-drug antibodies (ADAs) against JANX013 and JANX007
Time frame: Up to 2 years
Prostate-specific antigen (PSA) response
Time frame: Up to 2 years
Radiographic progression-free survival (rPFS)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
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JANX007 will be administered via IV dosing