Summary

Eligibility
for males ages 18-100 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion 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 JANX007 administered as a single agent in adults 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 ≥18 years of age at the time of signing informed consent
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • 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

You CAN'T join if...

  • Prior solid organ transplant
  • Prior treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies
  • 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
  • University of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 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 105 study participants
Last Updated