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drugset / Trial / NCT05519293

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

NCT05519293 ↗

Phase 1/2 Unknown 76 enrolled RedCloud Bio Parexel · collab
Non-randomizedSequentialOpen-labelTreatment

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).

Timeline

Start
2022-12-15
Primary completion
2025-02-28
Completion
2025-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject H002 Small molecule 20 mg Oral
Subject H002 Small molecule 40 mg Oral
Subject H002 Small molecule 80 mg Oral
Subject H002 Small molecule 150 mg Oral
Subject H002 Small molecule 250 mg Oral
Subject H002 Small molecule 350 mg Oral

Indications

non-small cell lung carcinoma