Phase I Study of HSK40118 in NSCLC Patients With EGFR Mutation

NSCLC Clinical Trial

Official title: 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

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

• 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