A Phase 2 Multicenter, Open-Label, Parallel Cohort Expansion Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-Mesenchymal-epithelial Transition Factor (c-MET) Dysregulation
Abion Inc
Summary
ABN401-003 is a Phase 2 clinical study to assess efficacy, safety, tolerability and pharmacokinetic profile of ABN401 (vabametkib) in specific populations of advance solid tumors with c-MET alterations as monotherapy.
Description
This study will start with one cohort and it will be a parallel cohort expansion study.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female ≥ 18 years of age or designated age of majority according to the regulatory authorities, whichever is higher. 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS), 0 or 1. 3. Have a life expectancy of at least 3 months. 4. Diagnosis: 1. must have histologically or cytologically confirmed NSCLC, advanced, recurrent, or metastatic, 2. For Cohort 1: MET exon 14 skipping suspected by local or central biomarker assessment. \[local testing is accepted for eligibility; all patients will have confirmation by central laboratory, but this res…
Interventions
- DrugVabametkib
Tablets Route of Administration: Oral
- DrugLazertinib
Tablets Route of Administration: Oral
Locations (24)
- Cancer Care of North Florida, PA (Lake City Cancer Care, LLC) - Medical OncologyLake City, Florida
- Mid Florida CenterOrange City, Florida
- The Henry Ford Cancer InstituteDetroit, Michigan
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- National Cancer CenterGoyang-si, Gyeonggi-do
- Ajou University HospitalSuwon, Gyeonggi-do