[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 HER2-expressing advanced 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] main purpose:
1. To assess the safety and tolerability of ZV0203 in subjects with HER2-expressing advanced solid tumors
2. Determine the maximum tolerated dose (MTD) or phase 2 recommended dose (RP2D) of ZV0203
Secondary purpose:
1. Evaluation of the pharmacokinetic (PK) profiles of ZV0203, total antibodies and Duo-5
2. Assess the preliminary antitumor activity of ZV0203
3. Determination of the immunogenicity of ZV0203
Exploratory Purpose:
To explore the relationship between tumor HER2 status and clinical response to ZV0203.