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).
Male participants ≥ 18 years of age at the time of signing informed consent
Histologically or cytologically confirmed adenocarcinoma of the prostate
Must be in the first-line or second-line setting for mCRPC or metastatic androgen pathway modulation resistant disease and must have received 1 novel ARPI in any setting.
Adequate organ function
Prior treatment with any chimeric antigen receptor (CAR) T-cell therapy, any approved or investigational TCE, or any T-cell costimulatory agent
Clinically significant cardiovascular disease
Prior solid organ transplant
Sequential
JANX013
DrugJANX013 will be administered via IV dosing.
JANX007
DrugJANX007 will be administered via IV dosing.
JANX013
DrugJANX013 will be administered via IV dosing
JANX007
DrugJANX007 will be administered via IV dosing
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Incidence of cytokine release syndrome (CRS)
Cytokine release syndrome (CRS) assessed according to ASTCT criteria.
Area under the curve from 0 to t of JANX013 and JANX007
Maximum observed concentration of JANX013 and JANX007
Time to maximum concentration of JANX013 and JANX007
Number of participants who develop anti-drug antibodies (ADAs) against JANX013 and JANX007
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