[Translation] A Phase I clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of XY003 in the treatment of advanced solid tumors.
Part 1剂量递增和回填阶段
主要目的:评价XY003治疗晚期实体瘤的安全性、耐受性,并确定最大耐受剂量(MTD)。
次要目的:评价XY003在晚期实体瘤患者中单次给药和多次给药的药代动力学(PK)特征,通过12导联心电图评估XY003对QT/QTc间期的影响;评价XY003在晚期实体瘤患者中的初步有效性。
Part 2(剂量扩展阶段)
主要目的:进一步评价XY003治疗HRD或NHEJ缺陷等DNA损伤修复缺陷晚期实体瘤的安全性和初步有效性,并确定II期推荐剂量(RP2D)。
次要目的:评价XY003在HRD或NHEJ缺陷等DNA损伤修复缺陷的晚期实体瘤患者的药代动力学(PK)特征。
[Translation] Part 1 (Dose Escalation and Refill Phase)
Primary Objective: To evaluate the safety and tolerability of XY003 in treating advanced solid tumors and to determine the maximum tolerated dose (MTD).
Secondary Objective: To evaluate the pharmacokinetic (PK) characteristics of XY003 in patients with advanced solid tumors after single and multiple doses; to assess the effect of XY003 on the QT/QTc interval using 12-lead electrocardiography; and to evaluate the preliminary efficacy of XY003 in patients with advanced solid tumors.
Part 2 (Dose Expansion Phase)
Primary Objective: To further evaluate the safety and preliminary efficacy of XY003 in treating advanced solid tumors with DNA damage repair deficiencies such as HRD or NHEJ deficiency, and to determine the Phase II recommended dose (RP2D).
Secondary Objective: To evaluate the pharmacokinetic (PK) characteristics of XY003 in patients with advanced solid tumors with DNA damage repair deficiencies such as HRD or NHEJ deficiency.