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A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of YH25448 when given orally to participants with epidermal growth factor receptor single activating mutation positive (EGFRm+) locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC).
Primary Objective (Part D): To evaluate the safety, tolerability, and pharmacokinetics (PK) of YH25448 when given orally to patients with EGFRm+locally advanced NSCLC. Secondary Objectives: To characterize the PK profiles of potential YH25448 metabolites in plasma, including M7, following a single oral dose and at steady state. To obtain additional assessments of the anti-tumor activity of YH25448 by evaluation of objective response rate (ORR), duration of response (DoR), disease control rate (DCR), tumor shrinkage and progression free survival (PFS) using RECIST 1.1 as assessed by investigator review of radiological information and overall survival (OS).