An Open-label, Multicenter, Phase I Dose-escalation Study to Assess the Safety, Pharmacokinetic (PK), Immunogenicity and Preliminary Anti-tumor Activity of ZV0203 in Patients With HER2-Positive Advanced Solid Tumors

An open-label, multicenter, phase I dose-escalation study to assess the safety, Pharmacokinetic (PK), immunogenicity and preliminary anti-tumor activity of ZV0203 in patients with HER2-Positive advanced solid tumors

Start Date17 Dec 2021

Sponsor / Collaborator

Hangzhou Adcoris Biopharmacy Co., LtdStartup

CTR20212848 / RecruitingPhase 1

一项在表达 HER2 的晚期实体瘤患者中评估 ZV0203 的安全性、药代动力学、免疫原性及其初步抗肿瘤活性的开放、多中心的 1 期剂量递增研究

[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.

Start Date17 Dec 2021

Sponsor / Collaborator

Zhejiang Hisun Pharmaceutical Co., Ltd.

[+2]

100 Clinical Results associated with ADC-2122

100 Translational Medicine associated with ADC-2122

100 Patents (Medical) associated with ADC-2122

Literatures (Medical) associated with ADC-2122

01 Jan 2023·Journal of Pharmacological and Toxicological Methods

Development of a bridging ELISA for detection of antibodies against ZV0203 in cynomolgus monkey serum

Article

Author: Fang, Wenjing ; Sun, Jianhua ; Chen, Xiaoqiang ; Gao, Jinli ; Ju, Dianwen ; Qin, Qiuping ; Gong, Likun ; Wu, Junliang ; Fan, Xiaotian ; Cao, Sheldon ; Peng, Xionghua ; Tong, Yongliang ; Liu, Tingting ; Li, Zhaohui

Immunogenicity has been a major concern in the safety evaluation of therapeutic proteins. The assessment of the unwanted immunogenicity of the therapeutic proteins performed in animals prior to clinical trials has been a regulatory requirement. In preclinical studies of therapeutic proteins, cynomolgus monkeys are usually the most relevant animal species. ZV0203, a recombinant humanized anti-human epidermal growth factor receptor 2 monoclonal antibody covalently bound to a cytotoxic drug (Duo-5), possesses a novel format of antibody drug conjugates. In this study, we reported the development, validation, and application of a bridging enzyme-linked immunosorbent assay for the detection of antibodies against ZV0203 in cynomolgus monkey serum. Drug interference at low positive control (18.0 ng/mL) and high positive control (130 ng/mL) of anti-ZV0203 antibodies was not observed when ZV0203 concentration is below 1.74 μg/mL and 1.49 μg/mL, respectively. In addition, no interference was found from mouse IgG1, but interference was observed with human IgG1. No effect of hemolysis was found on the analysis results of the testing samples present in 100% pooled rabbit serum containing 2% (V/V) erythrocyte hemolysates. Besides, spiked anti-ZV0203 antibody in rabbit serum was stable after 5 freeze/thaw cycles. The results showed that the method is suitable for the detection of anti-ZV0203 antibodies in cynomolgus monkey serum. The assay was also successfully applied in the repeated dose study of ZV0203.

100 Deals associated with ADC-2122

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	CN	Hangzhou Adcoris Biopharmacy Co., LtdStartup	17 Dec 2021
HER2 Positive Solid Tumors	Phase 1	CN	Zhejiang Zova Biotherapeutics,Inc.	17 Dec 2021
HER2 Positive Solid Tumors	Phase 1	CN	Hangzhou Adcoris Biopharmacy Co., LtdStartup	17 Dec 2021
HER2 Positive Solid Tumors	Phase 1	CN	Zhejiang Hisun Pharmaceutical Co., Ltd.	17 Dec 2021

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05423977 (ESMO2023) Manual	Phase 1	HER2 Positive Solid Tumors HER2 positive	15	ZV0203	(ktwoinjwzh) = uqgjhuokjy hrksmuptdj (susudkjmjr ) View more	Positive	21 Oct 2023

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