[Translation] An open-label, multicenter, phase 1 dose-escalation study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary antitumor activity of ZV0203 in patients with advanced HER2-expressing solid tumors
主要目的:
1.评估ZV0203在表达HER2的晚期实体瘤受试者中的安全性和耐受性
2.确定ZV0203的最大耐受剂量(MTD)或2期推荐剂量(RP2D)
次要目的:
1.评估ZV0203、总抗体和Duo-5的药代动力学(PK)特征
2.评估ZV0203的初步抗肿瘤活性
3.确定ZV0203的免疫原性
探索性目的:
探讨肿瘤HER2状态和对ZV0203的临床反应之间的关系。
[Translation] Primary objectives:
1. To evaluate the safety and tolerability of ZV0203 in subjects with advanced solid tumors expressing HER2
2. To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of ZV0203
Secondary objectives:
1. To evaluate the pharmacokinetic (PK) characteristics of ZV0203, total antibody, and Duo-5
2. To evaluate the preliminary anti-tumor activity of ZV0203
3. To determine the immunogenicity of ZV0203
Exploratory objectives:
To explore the relationship between tumor HER2 status and clinical response to ZV0203.