[Translation] A multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LIT-00814 tablets in subjects with advanced solid tumors/esophageal cancer
主要研究目的
评价口服LIT-00814片在晚期实体瘤患者中的安全性和耐受性。
确定药物可能出现的最大耐受剂量(MTD)和II期推荐剂量(RP2D)。
次要研究目的
评价LIT-00814片在晚期实体瘤患者中药代动力学(PK)特征。
评估LIT-00814片在晚期实体瘤患者中的初步疗效。
评估生物标志物与LIT-00814片抑瘤活性的关系。
[Translation] Main study objectives
Evaluate the safety and tolerability of oral LIT-00814 tablets in patients with advanced solid tumors.
Determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the drug.
Secondary study objectives
Evaluate the pharmacokinetic (PK) characteristics of LIT-00814 tablets in patients with advanced solid tumors.
Evaluate the preliminary efficacy of LIT-00814 tablets in patients with advanced solid tumors.
Evaluate the relationship between biomarkers and the anti-tumor activity of LIT-00814 tablets.