[Translation] A multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of HLN601 liposome for injection in patients with advanced solid tumors
主要目的:
?评价HLN601治疗晚期实体瘤患者的安全性和耐受性,并确定其剂量限制性毒性(DLT)、最大耐受剂量(MTD)/最大给药剂量(MAD)及II期临床推荐剂量(RP2D)。
次要目的:
?评价HLN601在晚期实体瘤患者中的药代动力学(PK)特征,并获取药代动力学参数。
?评价HLN601的初步抗肿瘤活性,为后续临床试验推荐剂量和给药方案提供依据。
探索目的:
UGT1A1基因多态性与安全性关系、耐受性关系。
[Translation] Main purpose:
? To evaluate the safety and tolerability of HLN601 in the treatment of patients with advanced solid tumors, and to determine its dose-limiting toxicity (DLT), maximum tolerated dose (MTD)/maximum administered dose (MAD) and phase II clinical recommended dose (RP2D).
Secondary purpose:
? To evaluate the pharmacokinetic (PK) characteristics of HLN601 in patients with advanced solid tumors and obtain pharmacokinetic parameters.
? To evaluate the preliminary anti-tumor activity of HLN601 and provide a basis for the recommended dose and dosing regimen for subsequent clinical trials.
Exploration purpose:
Relationship between UGT1A1 gene polymorphism and safety and tolerability.