[Translation] An open, multicenter, phase I clinical study to evaluate the safety, efficacy, and pharmacokinetic characteristics of KY0135 tablets in the treatment of patients with advanced solid tumors
主要目的:1、评价KY0135片在晚期实体瘤患者中的安全性和耐受性。2、、确定KY0135片的最大耐受剂量(MTD)或最大爬坡剂量(MAD),以及后续推荐剂量(RD)。
次要目的:1、描述KY0135片单次、多次口服给药后的药代动力学特征。2、评价KY0135片在晚期实体瘤患者中的抗肿瘤活性。3、检测口服KY0135片后PD指标(头发毛囊的Axin2mRNA水平、血清骨转换生化指标如β-CTX)的变化。
[Translation] Primary objectives: 1. To evaluate the safety and tolerability of KY0135 tablets in patients with advanced solid tumors. 2. To determine the maximum tolerated dose (MTD) or maximum escalation dose (MAD) of KY0135 tablets, as well as the subsequent recommended dose (RD).
Secondary objectives: 1. To describe the pharmacokinetic characteristics of KY0135 tablets after single and multiple oral administration. 2. To evaluate the antitumor activity of KY0135 tablets in patients with advanced solid tumors. 3. To detect changes in PD indicators (Axin2 mRNA levels in hair follicles, serum bone turnover biochemical indicators such as β-CTX) after oral administration of KY0135 tablets.