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 JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Male ≥18 years of age at the time of signing informed consent
Histologically or cytologically confirmed adenocarcinoma of the prostate
For Dose Escalation: 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
Prior solid organ transplant
Prior treatment with any CAR-T cell therapy, approved or investigational T-cell engager therapy, and prior receipt of radioligand therapy
Clinically significant cardiovascular disease
Sequential
JANX014
Biological/VaccineJANX014 will be administered via IV dosing
Incidence of Dose Limiting Toxicities (DLTs)
Incidence of adverse events (AE) and Serious Adverse Events (SAE)
Area under the curve from time 0 to t of JANX014 (AUC0-t)
Maximum observed concentration of JANX014 (Cmax)
Number of participants who develop anti-drug antibodies against JANX014
Prostate Specific Antigen (PSA) response
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