Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-19-053
Prinicipal Investigator
Ma, Patrick
Phase
Phase I/II
Age Group
Adult
Scope
National
Secondary Protocol No.
APL-101-01
Title
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.


Applicable Disease Sites
Lung
Status
Open
Participating Institutions
Hershey Medical Center