Recombinant humanized monoclonal antibody against human epidermal growth factor receptor for injection conjugated a dolastatin derivative DUO5-杭州爱科瑞思生物医药有限公司

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

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

2，Age of 18 to 80 at the time of ICF.

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

4，At least one evaluable tumor lesion per RECIST 1.1.

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

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

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

8，Adequate hematology and organ function.

9，The life expectancy of the patients ≥12 weeks.

10，For 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.

11，For 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.