To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation
Trial Parameters
Brief 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.
Eligibility Criteria
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. \[local testing is accepted for eligibility; all patients will have confirmation by central laboratory, but this result is not necessary for eligibility; local molecular pathology result will suffice\]. This testing can be from archival or fresh tissue sample and/or blood specimen; any sample, any test positive subjects are eligible. 3. For Cohort 2: * Non-squamous histology (confirmed by histology or cytology) * EGFR mutation-positive including exon 19 deletions or exon 21 L858R as detected by an FDA-approved or other