Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC

A Phase 1 Open-Label, Multicenter Study of JANX013 Combined With JANX007 in Participants With Metastatic Castration Resistant Prostate Cancer

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).

Key Inclusion Criteria:

• Male participants ≥ 18 years of age at the time of signing informed consent
• Histologically or cytologically confirmed adenocarcinoma of the prostate

For Dose Escalation:

- Have received at least 1 novel ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, or darolutamide) in any setting and have received at least 1 taxane regimen (in any setting), or who are medically unsuitable or have actively refused treatment with a taxane regimen.

For Dose Expansion:

• 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

Key Exclusion Criteria:

• 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