Part A (Dose Escalation Phase) Approximately 36 subjects will be enrolled, based on the 3+3 design for dose escalation and safety evaluation requirements. The total number of subjects will depend upon the number of dose escalations necessary.~Part B (Dose Expansion Phase) Up to 20 subjects will be enrolled in each expansion arm, the total number of subjects will depend upon the number of dose expansions (expansions may be at more than one dose depending upon emerging data).
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 EGFR mutation-positive 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).