Phase I/IIa Study of H002 in NSCLC With Active EGFR Mutation

Non-small Cell Lung Cancer Clinical Trial

Official title: A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients With Active EGFR Mutation Locally Advanced or Metastatic NSCLC

Status Recruiting

Clinical Trial Summary

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 active EGFR mutation 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).

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

• NCT number: NCT05519293
• Study type: Interventional
• Source: RedCloud Bio
• Contact: Anna Chen
• Phone: +886 2 2176-9685
• Email: Anna.Chen@parexel.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 15, 2022
• Completion date: February 28, 2025