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).
Male ≥18 years of age at the time of signing informed consent
Histologically or cytologically confirmed adenocarcinoma of the prostate
For Dose Escalation and Backfill: 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 PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy
Clinically significant cardiovascular disease
For Monotherapy Expansion Part a: Prior receipt of any treatment other than an ARPI or taxane in the mCRPC setting
Sequential
JANX007
Biological/VaccineJANX007 is dosed via IV in a 21- or 28-day cycle.
Darolutamide
DrugDarolutamide is dosed via oral tablets
Incidence of Dose Limiting Toxicities (DLT)
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Area under the concentration time curve to infinity of JANX007 (AUC0-inf)
Maximum observed concentration of JANX007 (Cmax)
Number of participants who develop anti-drug antibodies against JANX007
Duration of Response
Time from documentation of complete response or partial response to disease progression using RECIST v1.1 and PCWG3
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