[Translation] An open-label, dose-escalation and dose-expansion Phase I clinical trial evaluating the safety, pharmacokinetics and efficacy of HW071021 tablets in patients with advanced solid tumors
本研究将评估HW071021片单药治疗晚期实体瘤的安全性、耐受性、药代动力学和初步有效性。主要目的:评估HW071021片单药用于晚期实体瘤患者的安全性和耐受性。次要目的:评估HW071021片口服给药的人体PK特征;评估HW071021片在预设剂量下口服给药后可能出现的剂量限制性毒性(DLT)及最大耐受剂量(MTD)(仅第一阶段);确定HW071021片单药治疗在晚期实体瘤患者中II期推荐剂量(RP2D);评估不同剂量HW071021片对受试者QT/QTc间期的影响(仅第一阶段);初步评估HW071021片单药治疗对晚期实体瘤的疗效。探索性目的:探索HW071021片最佳获益的人群。
[Translation] This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HW071021 tablets as a monotherapy for advanced solid tumors. Primary objective: To evaluate the safety and tolerability of HW071021 tablets as a monotherapy in patients with advanced solid tumors. Secondary objectives: To evaluate the human PK characteristics of oral administration of HW071021 tablets; To evaluate the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) that may occur after oral administration of HW071021 tablets at a preset dose (Phase I only); To determine the Phase II recommended dose (RP2D) of HW071021 tablets as a monotherapy in patients with advanced solid tumors; To evaluate the effects of different doses of HW071021 tablets on the QT/QTc interval of subjects (Phase I only); To preliminarily evaluate the efficacy of HW071021 tablets as a monotherapy for advanced solid tumors. Exploratory objective: To explore the population that benefits best from HW071021 tablets.