A Phase I Study of Epitinib(HMPL-813) in Patients With Advanced Solid Tumors

Summary

Epitinib (HMPL-813) is a selective EGFR tyrosine kinase inhibitor. Epitinib has demonstrated strong inhibitory effects on multiple tumors with overexpressed EGFR or sensitive EGFR mutations in pre-clinical setting. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), safety and tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of Epitinib.

Timeline

Start

2011-10-31

Primary completion

2019-04-30

Completion

2019-04-30

Publications

• Zhou Q, Wang M, Zhang H, Hong Q, Liu X, Lu P, Su W, Wu YL. Safety and Efficacy of Epitinib for EGFR-Mutant Non-Small Cell Lung Cancer With Brain Metastases: Open-Label Multicentre Dose-Expansion Phase Ib Study. Clin Lung Cancer. 2022 Sep;23(6):e353-e361. doi: 10.1016/j.cllc.2022.03.014. Epub 2022 May 7.

Drugs

Indications