[Translation] An open-label, multicenter, dose-escalation and dose-expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and efficacy of NC18 in patients with HER2-positive or HER2-expressing advanced solid tumors
(1)主要目的:评估NC18在HER2阳性或表达的晚期实体瘤患者中的安全性和耐受性,确定NC18使用的最大耐受剂量(MTD)和II期推荐剂量(RP2D)。
(2)次要目的:评估NC18的药代动力学(PK)特征、免疫原性和有效性。
[Translation] (1) Primary objective: To evaluate the safety and tolerability of NC18 in patients with HER2-positive or HER2-expressing advanced solid tumors, and to determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of NC18.
(2) Secondary objective: To evaluate the pharmacokinetic (PK) characteristics, immunogenicity and efficacy of NC18.