[Translation] A Phase Ia clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of single and multiple oral administration of HTMC0370 tablets in patients with advanced solid tumors
1. 主要目的:评价单次和多次口服HTMC0370片在晚期实体瘤患者中的安全性和耐受性;探索MTD,为II期临床推荐给药剂量的确定提供依据。2. 次要目的:考察HTMC0370片单、多次口服给药的PK特征;初步观察HTMC0370片对晚期实体瘤的抗肿瘤活性;考察生物标志物的表达水平与HTMC0370抑瘤活性的关系。
[Translation] 1. Primary objectives: To evaluate the safety and tolerability of single and multiple oral administration of HTMC0370 tablets in patients with advanced solid tumors; to explore the MTD and provide a basis for determining the recommended dosage for Phase II clinical trials. 2. Secondary objectives: To investigate the PK characteristics of single and multiple oral administration of HTMC0370 tablets; to preliminarily observe the anti-tumor activity of HTMC0370 tablets against advanced solid tumors; to investigate the relationship between the expression level of biomarkers and the anti-tumor activity of HTMC0370.