[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of HG381 monotherapy in patients with advanced solid tumors
主要目的:评价HG381在晚期实体瘤患者中的安全性和耐受性,并探索HG381在晚期实体瘤患者中的剂量限制性毒性(DLT)、最大耐受剂量(MTD)。
次要目的:评估HG381在晚期实体瘤患者中的药代动力学(PK)特征;确定II期推荐剂量(RP2D);初步评价HG381在晚期实体瘤患者中的疗效;评估HG381在晚期实体瘤患者中的药效学(PD)特征;探索TMEM173单核苷酸多态性及其与HG381的疗效和安全性的相关性。
[Translation] Primary objectives: To evaluate the safety and tolerability of HG381 in patients with advanced solid tumors, and to explore the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of HG381 in patients with advanced solid tumors.
Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of HG381 in patients with advanced solid tumors; to determine the recommended dose (RP2D) for Phase II; to preliminarily evaluate the efficacy of HG381 in patients with advanced solid tumors; to evaluate the pharmacodynamic (PD) characteristics of HG381 in patients with advanced solid tumors; to explore TMEM173 single nucleotide polymorphisms and their correlation with the efficacy and safety of HG381.