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Official Title
An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
Phase
Phase 1
Sponsor
Janux Therapeutics
Enrollment
130
Timeline
Apr 2023 → Oct 2027
About This Study
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 Criteria
Inclusion Criteria
- 1Subjects ≥18 years of age at the time of signing informed consent
- 2Histologically or cytologically documented locally advanced or metastatic NSCLC, SCCHN, CRC, RCC, SCLC, PDAC, TNBC
- 3Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for the tumor type
- 4Adequate organ function
- 5At least 1 measurable lesion per RECIST 1.1
Exclusion Criteria
- 1Treatment with anti-cancer therapy within 28 days or ≤5 elimination half-lives, whichever is earlier, before enrollment
- 2Prior treatment with EGFR-targeted bispecific T cell engager or CAR-T cell therapy
- 3Prior treatment with CD3 engaging bispecific antibodies
- 4Clinically significant cardiovascular diseases
- 5Active clinically significant infection (bacterial, viral, fungal, mycobacteria, or other)
- 6On supplemental oxygen
- 7Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
Locations
18 sites participating in this study
Winship Cancer Institute, Emory University
Atlanta, Georgia 30308
City of Hope Medical Center
Duarte, California 91010
University of California, Davis Comprehensive Cancer Center
Sacramento, California 95817
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →