小分子EGFR酪氨酸激酶不可逆抑制剂Hemay020胶囊用于晚期实体瘤的Ⅰ期临床试验
主要目的:评估Hemay020胶囊在晚期实体瘤患者的安全性和耐受性以及药代动力学特征。 次要目的:考察食物对Hemay020胶囊的影响并进行初步疗效评价,探索EGFR基因突变与疗效的相关性
Phase I Trial Evaluating Pharmacokinetics, Safety and Tolerability of the Irreversible Epidermal Growth Factor Receptor Inhibitor Hemay020 in Patients With Advanced Solid Cancer
The purpose of this study is to assess the pharmacokinetics,safety and tolerability of Hemay020 and to determine the recommended dose for future Phase II study as well as to obtain preliminary information on the efficacy of Hemay020 in subjects with solid tumors. The study will be conducted in two parts. Part one, testing will be done on up to 16-31 subjects to determine the safety and tolerability of Hemay 020 in patients with advanced solid tumors. Part two, another 16-24 subjects with advanced or metastatic NSCLC, will be added to the trial to better define the tolerability and preliminary efficacy of Hemay020.
100 项与 Hemay-020 相关的专利(医药)