Pipeline

Subject Recruitment

Recombinant humanized monoclonal antibody against human epidermal growth factor receptor for injection conjugated a dolastatin derivative DUO5

Recruitment Notice

An open, multicenter Phase I dose-escalation study sponsored by Hangzhou Adcoris Biopharma Co., Ltd. to evaluate the safety, pharmacokinetics, immunogenicity, and initial antitumor activity of ZV0203 in patients with advanced solid tumors expressing HER2 is ongoing. The clinical trial has been approved by NMPA and approved by the ethics committee of each hospital respectively. Subjects are currently being recruited.

Participation Criteria


1Willing and able to sign a written informed consent form (ICF).

2Age of 18 to 80 at the time of ICF.

3Pathological diagnosis of unresectable locally advanced or metastatic solid tumor, failure to standard treatment or intolerance or inapplicable of standard treatment.

4At least one evaluable tumor lesion per RECIST 1.1.

5Human epidermal growth factor receptor 2 (HER2) positive tumors: Defined as immunohistochemical (IHC) 3+, or IHC 2+ and in situ hybridization positive.

6Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

7Echocardiography or multi-gated acquisition scans show left ventricular ejection fraction (LVEF) ≥ 50%.

8Adequate hematology and organ function.

9The life expectancy of the patients ≥12 weeks.

10For women with reproductive potential, the pregnancy test must be negative at the time of study and consent to the use of highly effective contraception after enrollment, during treatment and within 90 days after the last administration of the study drug.

11For male subject, must have been sterilized or consented to use of highly effective contraception after enrollment, during treatment and for 90 days after the last administration of the study drug.




Contact information

Shanghai East Hospital (Leading site)

Contact: Yincui Ding

Tel: 08613301433157

Email: yincui.ding@startshanghai.cn


Shandong Cancer Hospital

Contact: Xue Zhao

Tel: 08615615776727

Email: xue.zhao@startshanghai.cn


The First Affiliated Hospital of Nanchang University

Contact: Shuangshuang Wu

Tel: 08615170405898

Email: shuangshuang.wu@startshanghai.cn