Phase I/IIa Study of H002 in NSCLC With Active EGFR Mutation
Trial Parameters
Brief Summary
This is a phase I/IIa, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of H002 when given orally in patients with active EGFR mutation locally advanced or metastatic non-small cell lung cancer (NSCLC). The study will contain two parts: Part A is dose escalation phase (i.e., Phase I) and Part B is dose expansion phase (i.e., Phase IIa).
Eligibility Criteria
Inclusion Criteria: 1. Males or females aged ≥ 18 years at time of signing informed consent form (ICF). 2. Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC. 3. Subjects must have NSCLC harboring one or more active EGFR mutations known to be associated with EGFR-TKI sensitivity (including, but not limited to Del19 and L858R). * Part A: All subjects may provide tumor sample to central laboratory to analyze the EGFR mutation status according to their own willingness; * Part B: All subjects must provide tumor sample to central laboratory to analyze the EGFR mutation status. And subjects must have NSCLC harboring EGFR C797S mutation. Note: Tumor sample can be either an archival sample or a sample obtained by pretreatment biopsy prior to H002 treatment. 4. Subjects must have radiological documented disease progression while on a previous continuous treatment with osimertinib or another third-generation EGFR-TKI as well as disease progressio