JANX014 for metastatic castration-resistant 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 first-in-human, open-label Phase 1 study gives JANX014 to adults with metastatic castration-resistant prostate cancer to define safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary signs of anti-tumor activity. The study uses a dose-escalation phase to identify a tolerable dose and a dose-expansion phase to further characterize safety and early efficacy signals. Eligible participants generally must have progressed after at least one novel anti-androgen and typically a prior taxane regimen, although those who refused or cannot receive taxane may qualify. The trial excludes patients with prior CAR-T or T-cell engager therapy, prior radioligand therapy, prior solid organ transplant, or significant cardiovascular disease and is conducted at a research site in Nashville, Tennessee.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* For Dose Expansion Part: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.

Exclusion Criteria:

* 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

Where it's running

• UC San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• Medical University of South Carolina - Hollings Cancer Center
  Charleston, South Carolina, United States Recruiting
• Prisma Health Cancer Institute
  Greenville, South Carolina, United States Recruiting
• SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting
• SCRI at Mary Crowley
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Janux Therapeutics, MD
• Email: PRCA-014-001_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.