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
The primary Phase 1 purpose of this study is to assess overall safety and tolerability and recommended Phase 2 dose (RP2D) of APL-101. The Phase 2 portion will assess efficacy of the dose determined in Phase 1 in individuals with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Phase I Primary Objective To assess overall safety and tolerability, determine the dose limiting toxicities (DLTs), and identify the recommended Phase 2 dose (RP2D). Phase II Primary Objective: To assess efficacy by overall response rate (ORR) and duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. or relevant evaluation criteria per tumor type. Phase I/II Secondary Objectives: 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 + P R + S D ≥ 4 cycles), time to progression (TTP), progression free survival (PFS), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (or relevant evaluation criteria per tumor type) and overall survival (OS). Phase I/II Exploratory Objectives: 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.
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