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Clinical Trial Summary

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.


Clinical Trial Description

Phase Ia will contain two part: Dose Escalation Part(Part A) and Extension Part(Part B). Part A based on the "3+3" design for dose escalation and safety evaluation requirements. Patient cohorts at selected doses may be extended to further investigate the tolerability, PK and PD of HSK40118. The number of patients to be enrolled will be up to 10 subjects in each Part B cohort. Approximately 30-70 subjects will be enrolled in Phase Ia. Phase Ib no less than 130 subjects will be enrolled in each expansion cohort, cohort A will be enrolled 30-50 subjects, cohort B will be enrolled no less than 100 subjects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06050980
Study type Interventional
Source Haisco Pharmaceutical Group Co., Ltd.
Contact Fangqiong Li
Phone +8602867258840
Email lifangq@haisco.com
Status Recruiting
Phase Phase 1
Start date March 27, 2023
Completion date June 7, 2027

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