JANX013 and JANX007 combo in advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, open-label, multicenter study to evaluate safety, tolerability, PK, PD, and preliminary anti-tumor activity of JANX013 in combination with JANX007 in men with metastatic castration-resistant prostate cancer. The trial uses a dose-escalation design to identify safe dose levels, followed by a dose-expansion phase in patients who have progressed after standard ARPI therapy and taxane treatment or who are unsuitable for taxanes. Eligible participants are adult men with confirmed prostate cancer, adequate organ function, and prior ARPI exposure. Exclusion includes prior CAR-T or T-cell therapies and significant cardiovascular disease.

Why it matters

Who can join: the full rules

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

Where it's running

• Sarah Cannon Research Institute
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Janux Therapeutics, MD
• Email: PSMA-013-001_ct.gov@januxrx.com
• Phone: 1-858-206-8471

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.