[Translation] A multicenter, open-label, dose-escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor efficacy of oral POC101 capsules in Chinese patients with advanced solid tumors
主要目的:
评估POC101在晚期实体瘤患者中的安全性和耐受性;
观察POC101的剂量限制性毒性(DLT),确定POC101在晚期实体瘤患者中的最大耐受剂量(MTD)和/或II期推荐剂量(RP2D)。
次要目的:
评估POC101在晚期实体瘤患者中的药代动力学(PK)特征、食物影响和代谢产物鉴定;
评估POC101在晚期实体瘤患者中的初步抗肿瘤活性和肿瘤生物标志物(如适用)的变化情况。
[Translation] Primary objectives:
Evaluate the safety and tolerability of POC101 in patients with advanced solid tumors;
Observe the dose-limiting toxicity (DLT) of POC101 and determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D) of POC101 in patients with advanced solid tumors.
Secondary objectives:
Evaluate the pharmacokinetic (PK) characteristics, food effects, and metabolite identification of POC101 in patients with advanced solid tumors;
Evaluate the preliminary anti-tumor activity of POC101 in patients with advanced solid tumors and changes in tumor biomarkers (if applicable).