Summary

Eligibility
for males ages 18-100 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

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 JANX007 administered as a single agent in adult subjects with metastatic castration-resistant prostate cancer (mCRPC).

Official Title

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

Keywords

Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic Cancer, Castration-resistant prostate cancer, Prostatic Neoplasms, Castration-Resistant Prostatic Neoplasms, JANX007, Backfill Expansion, Expansion

Eligibility

You can join if…

Open to males ages 18-100

  • Male subjects ≥18 years of age at the time of signing informed consent
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Subjects with mCRPC who progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Subjects who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible
  • PSMA expressing tumor
  • Adequate organ function

You CAN'T join if...

  • Prior solid organ transplant
  • Prior treatment with PSMA-targeted CAR-T cell therapy
  • Clinically significant cardiovascular disease
  • Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)
  • Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States
  • Mary Crowley Cancer Research accepting new patients
    Dallas Texas 75230 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janux Therapeutics
ID
NCT05519449
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated