[Translation] An open, multicenter phase I clinical study of the safety, tolerability, pharmacokinetics and efficacy of HRS-6208 in patients with solid tumors
主要目的:
1. 评价HRS-6208在晚期实体瘤患者中的安全性和耐受性。
2. 确定HRS-6208单药在晚期实体瘤患者中的剂量限制性毒性(DLT),确定最大耐受剂量(MTD)和II期临床研究推荐剂量(RP2D)。
次要目的:
1. 评估HRS-6208在晚期实体瘤患者中的药代动力学(PK)特征。
2. 初步评价HRS-6208食物效应。
3. 初步评价HRS-6208在晚期实体瘤患者中的疗效。
[Translation] Primary objectives:
1. To evaluate the safety and tolerability of HRS-6208 in patients with advanced solid tumors.
2. To determine the dose-limiting toxicity (DLT) of HRS-6208 monotherapy in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and recommended dose (RP2D) for Phase II clinical studies.
Secondary objectives:
1. To evaluate the pharmacokinetic (PK) characteristics of HRS-6208 in patients with advanced solid tumors.
2. To preliminarily evaluate the food effect of HRS-6208.
3. To preliminarily evaluate the efficacy of HRS-6208 in patients with advanced solid tumors.