Phase 1/2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Objective
Phase 1 / 2 Secondary Objective(s) The secondary objective(s) of this study is (are): To assess incidence of serious adverse events (SAEs) and adverse events (AEs) by relationship and severity grade. To determine the pharmacokinetic (PK) parameters of orally administered APL-101. To assess efficacy by clinical benefit rate (CBR: CR + PR + SD ≥ 4 cycles), time to progression (TTP), progression free survival (PFS), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (or relevant criteria per tumor type) and overall survival (OS).
Phase 1 / 2 Exploratory Objective(s) To evaluate potential pharmacodynamic (PD) biomarkers of APL-101 and its correlation to the PK profile. To evaluate relationship of relevant biomarkers, including c-Met protein expression, amplification, and/or mutations to clinical response.