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

Janux Therapeutics

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 in adults with metastatic castration-resistant prostate cancer (mCRPC).

Eligibility

Age range: 18–100 years
Sex: Male
Healthy volunteers: No

Detailed criteria

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 and Backfill: 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 Monotherapy Expansion Part a: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1…

Locations (36)

University of Alabama at Birmingham Hospital
Birmingham, Alabama
Mayo Clinic
Phoenix, Arizona
USC Norris Comprehensive Cancer Center
Los Angeles, California
UCLA Department of Medicine
Los Angeles, California
Hoag Memorial Hospital Presbyterian
Newport Beach, California
University of California Davis Comprehensive Cancer Center
Sacramento, California

Summary

Eligibility

Interventions

Locations (36)