[Translation] A dose-escalation, open-label phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HS236 capsule, a small molecule covalent inhibitor of FGFR4, in patients with advanced solid tumors
主要目的:评价HS236胶囊在晚期实体瘤患者的安全性和耐受性,并探索HS236的最大耐受剂量(MTD),确定Ⅱ期临床试验推荐剂量(RP2D)。
次要目的:
1)评价HS236的药代动力学(PK)和药效动力学(PD)特征;
2)初步评价HS236的抗肿瘤疗效;
3)初步评价HS236抗肿瘤疗效与生物标志物的相关性,为Ⅱ期临床试验的治疗人群选择提供依据。
[Translation] Primary objective: To evaluate the safety and tolerability of HS236 capsules in patients with advanced solid tumors, explore the maximum tolerated dose (MTD) of HS236, and determine the recommended dose (RP2D) for Phase II clinical trials.
Secondary objectives:
1) To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of HS236;
2) To preliminarily evaluate the anti-tumor efficacy of HS236;
3) To preliminarily evaluate the correlation between the anti-tumor efficacy of HS236 and biomarkers, and provide a basis for the selection of treatment populations for Phase II clinical trials.