[Translation] A single-arm, open-label Phase I clinical trial to evaluate the tolerability, safety, pharmacokinetic characteristics and preliminary efficacy of HEC81885 p-toluenesulfonate in subjects with advanced solid tumors
1. 主要目的:
1) 评估HEC81885对甲苯磺酸盐在晚期实体瘤受试者中的安全性和耐受性;观察剂量限制毒性(DLT),确定最大耐受剂量(MTD)或扩展推荐剂量(RED),为HEC81885对甲苯磺酸盐后续临床试验的推荐给药剂量和给药方案提供依据;
2) 评估HEC81885对甲苯磺酸盐在晚期实体瘤中的疗效。
2. 次要目的:
1) 观察人体中的HEC81885对甲苯磺酸盐的药代动力学特征,鉴定其主要代谢产物;
2) 观察肿瘤组织中c-Met、Axl蛋白过表达,以及c-Met或其他基因扩增或突变与HEC81885对甲苯磺酸盐疗效的相关性。
[Translation] 1. Primary objectives:
1) To evaluate the safety and tolerability of HEC81885 p-toluenesulfonate in subjects with advanced solid tumors; to observe dose-limiting toxicity (DLT), determine the maximum tolerated dose (MTD) or extended recommended dose (RED), and provide a basis for the recommended dosage and dosing regimen of subsequent clinical trials of HEC81885 p-toluenesulfonate;
2) To evaluate the efficacy of HEC81885 p-toluenesulfonate in advanced solid tumors.
2. Secondary objectives:
1) To observe the pharmacokinetic characteristics of HEC81885 p-toluenesulfonate in humans and identify its main metabolites;
2) To observe the correlation between the overexpression of c-Met and Axl proteins in tumor tissues, and the amplification or mutation of c-Met or other genes and the efficacy of HEC81885 p-toluenesulfonate.