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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). ;


Study Design


Related Conditions & MeSH terms


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

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