An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
Janux Therapeutics
Summary
This study is a first-in-human (FIH), Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR.
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects ≥18 years of age at the time of signing informed consent * Histologically or cytologically documented locally advanced or metastatic NSCLC, SCCHN, CRC, RCC, SCLC, PDAC, TNBC * Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for the tumor type * Adequate organ function * At least 1 measurable lesion per RECIST 1.1 Exclusion Criteria: * Treatment with anti-cancer therapy within 28 days or ≤5 elimination half-lives, whichever is earlier, before enrollment * Prior treatment with EGFR-targeted bispecific T cell e…
Interventions
- DrugJANX008
JANX008 is dosed via IV weekly in a 21-day cycle
Locations (18)
- City of Hope Medical CenterDuarte, California
- University of California, Davis Comprehensive Cancer CenterSacramento, California
- University of California San Diego Moores Cancer CenterSan Diego, California
- Winship Cancer Institute, Emory UniversityAtlanta, Georgia
- University of Chicago Medical CenterChicago, Illinois
- University of MichiganAnn Arbor, Michigan