[Translation] A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary antitumor activity of single and multiple oral doses of HTMC0503 tablets in patients with advanced solid tumors
1、主要目的:评价单次和多次口服HTMC0503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(RP2D)的确定提供依据。2、次要目的:评价HTMC0503片单、多次口服给药的PK特征;初步观察HTMC0503片对晚期实体瘤的抗肿瘤活性;考察基因突变与HTMC0503抗肿瘤活性的关系。
[Translation] 1. Primary objectives: To evaluate the safety and tolerability of single and multiple oral administration of HTMC0503 tablets in patients with advanced solid tumors; to explore the MTD and provide a basis for the determination of the recommended dose (RP2D) for Phase II clinical trials. 2. Secondary objectives: To evaluate the PK characteristics of single and multiple oral administration of HTMC0503 tablets; to preliminarily observe the anti-tumor activity of HTMC0503 tablets against advanced solid tumors; to investigate the relationship between gene mutations and the anti-tumor activity of HTMC0503.