Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
study ends around

Description

Summary

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).

Official Title

A Phase 1 Open-Label, Multicenter Study of JANX014 in Participants With Prostate Cancer

Keywords

Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration-resistant Prostate Cancer, Prostatic Neoplasms, JANX014

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92037 United States
  • SCRI at Mary Crowley accepting new patients
    Dallas Texas 75230 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janux Therapeutics
ID
NCT07545811
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 43 study participants
Last Updated