Phase I study of QLNC120, a novel EGFR and HER2 kinase inhibitor, in pre-treated patients with HER2-overexpressing advanced breast cancer.

ABSTRACT: This study evaluated the dose-limiting toxicities (DLT), maximum tolerated dose (MTD), pharmacokinetic profile, and preliminary antitumor activity of QLNC120, an inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2), in HER2 overexpressing advanced breast cancer patients. In addition, the prognostic biomarkers of QLNC120 were investigated. QLNC120 was administered as a single dose, followed by 7 days observation, and then once daily consecutively. Scheduled dose escalation was 450mg, 750mg, 1000mg and 1250mg. For pharmacokinetic analysis, blood samples were collected after the single dose and after the first 7 days of continuous administration. Tissue samples were collected for biomarker analysis. Twenty-four heavily treated HER2 overexpre

SUBMITTER: Zhang T 

PROVIDER: S-EPMC5482694 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature