A Phase I, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of HSK40118 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK40118 when given orally in patients with active EGFR mutation locally advanced or metastatic non-small cell lung cancer (NSCLC). The study will contain two phase: Phase Ia is dose escalation phase and Phase Ib is dose expansion phase.
• Age ≥ 18 years, Male and female patients, at time of signing informed consent form (ICF).
• ECOG=0-1, with no deterioration in 2 weeks before first dose of HSK40118.
• Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC.
• Patients will provide blood or tumor sample according to their own willingness.
• Patients in Phase Ia and Ib will fulfill the different criteria of the following:
• Phase Ia(Part A): Previous treatment with at least one EGFR-TKI, including 1st, 2nd and 3rd-generation EGFR-TKI; Phase Ia(Part B)/Phase Ib: Previous treatment with 3rd-generation EGFR-TKI.
• tumour lesions/lymph nodes: Phase Ia(Part A): Patients should have at least one assessable tumour lesions/malignant lymph nodes; Phase Ia(Part B) /Phase Ib: Patients should have at least one measurable tumour lesions/malignant lymph nodes.
• Life expectancy ≥ 3 months.
• Adequate hematologic and organ function per protocol.
• Women of childbearing potential (WOCBP) and fertile males with WOCBP partners must use highly effective contraception per protocol throughout and after 90 days of the last dose of the study.