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
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…
Interventions
- BiologicalJANX007
JANX007 is dosed via IV in a 21- or 28-day cycle.
- DrugDarolutamide
Darolutamide is dosed via oral tablets
Locations (35)
- University of Alabama at Birmingham HospitalBirmingham, Alabama
- Mayo ClinicPhoenix, Arizona
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- UCLA Department of MedicineLos Angeles, California
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- University of California Davis Comprehensive Cancer CenterSacramento, California