[Translation] Phase Ia/Ib Clinical Study Protocol for the Safety, Tolerability, and Pharmacokinetics of Oral FNX006 Tablets in Patients with Advanced Solid Tumors
主要目的
1)评估FNX006片口服给药在晚期实体瘤患者中的安全性和耐受性;
2)评价FNX006片口服给药在晚期实体瘤患者中的药代动力学特征;
次要目的
1)初步评价FNX006片在晚期三阴乳腺癌患者中的疗效;
2)探索FNX006片的药代动力学测量结果与其毒性和疗效变化情况之间的关系;
[Translation] Main purpose
1) To evaluate the safety and tolerability of oral administration of FNX006 tablets in patients with advanced solid tumors;
2) To evaluate the pharmacokinetic characteristics of oral administration of FNX006 tablets in patients with advanced solid tumors;
Secondary purpose
1) To preliminarily evaluate the efficacy of FNX006 tablets in patients with advanced triple-negative breast cancer;
2) To explore the relationship between the pharmacokinetic measurement results of FNX006 tablets and its toxicity and efficacy changes;