A Phase 1 Open-Label, Multicenter Study of JANX014 in Participants With 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 JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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…
Interventions
- BiologicalJANX014
JANX014 will be administered via IV dosing
Location
- Research SiteNashville, Tennessee