drugset / Trial / NCT05552781
H002 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC
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 EGFR mutation-positive 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
- 2022-08-26
- Primary completion
- 2025-02-28
- Completion
- 2025-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |