[Translation] A multicenter, open-label phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of LIT0922 capsules in patients with advanced solid tumors
主要目的: 1.评估 LIT0922 胶囊的安全性和耐受性; 2. 通过评估 LIT0922 胶囊在晚期实体瘤患者中的剂量限制性毒性(DLTs),确定最大耐受剂量(MTD);3. 确定 RP2D
次要目的: 1.评估 LIT0922 胶囊的药代动力学(PK)特征; 2.初步评估 LIT0922 胶囊的抗肿瘤活性; 3. 初步评估生物标记物与疗效之间的相关性
[Translation] Primary objectives: 1. Evaluate the safety and tolerability of LIT0922 capsules; 2. Determine the maximum tolerated dose (MTD) by evaluating the dose-limiting toxicities (DLTs) of LIT0922 capsules in patients with advanced solid tumors; 3. Determine the RP2D
Secondary objectives: 1. Evaluate the pharmacokinetic (PK) characteristics of LIT0922 capsules; 2. Preliminary evaluation of the anti-tumor activity of LIT0922 capsules; 3. Preliminary evaluation of the correlation between biomarkers and efficacy