NCT06050980

Phase I Study of HSK40118 in NSCLC Patients With EGFR Mutation

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	HSK40118	Oral administration, QD

Timeline

• Start date: 2023-03-27
• Primary completion: 2025-08-30
• Completion: 2027-06-07
• First posted: 2023-09-22
• Last updated: 2023-09-22

Locations

12 sites across 1 country: China