Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
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, or RCC 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 engager or CAR-T cell therapy Prior treatment with CD3 engaging bispecific antibodies Clinically significant cardiovascular diseases Active clinically significant infection (bacterial, viral, fungal, mycobacteria, or other) On supplemental oxygen Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
Sites / Locations
- City of Hope Medical CenterRecruiting
- Washington UniversityRecruiting
- The Christ Hospital Cancer CenterRecruiting
- Sarah Cannon Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Dose Escalation
Backfill Expansion
Expansion
Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).