[Translation] A multicenter, open-label, single-arm phase I dose-escalation and dose-expansion clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of XS-04 tablets in patients with relapsed or refractory hematological malignancies
主要目的:
评价XS-04片在复发或难治性血液系统恶性肿瘤患者中的安全性和耐受性。
确定XS-04片最大耐受剂量(Maximal tolerated dose,MTD)和/或II期临床研究推荐剂量(Recommended phase 2 dose,RP2D)。
次要目的:
确定XS-04片单次、多次口服给药后的药代动力学(Pharmacokinetics, PK)特征。
初步评价XS-04片在复发或难治性血液系统恶性肿瘤患者中的疗效。
探索性目的:
初步评估患者口服 XS-04片后的代谢转化特征。
评估群体PK和暴露-效应(E-R)关系。
探索相关生物标志物与药物疗效的关联;探索PD生物标记物与PK的相关性。
评估食物对患者口服XS-04片的PK特征影响。
[Translation] Primary objective:
Evaluate the safety and tolerability of XS-04 tablets in patients with relapsed or refractory hematological malignancies.
Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of XS-04 tablets.
Secondary objective:
Determine the pharmacokinetic (PK) characteristics of XS-04 tablets after single and multiple oral administration.
Preliminary evaluation of the efficacy of XS-04 tablets in patients with relapsed or refractory hematological malignancies.
Exploratory objective:
Preliminary evaluation of the metabolic conversion characteristics of patients after oral administration of XS-04 tablets.
Evaluate population PK and exposure-effect (E-R) relationships.
Explore the association between relevant biomarkers and drug efficacy; explore the correlation between PD biomarkers and PK.
Evaluate the effect of food on the PK characteristics of patients taking oral XS-04 tablets.