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Brief Title: A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer.
Official Title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in EGFR-Positive, HER2-Negative Advanced Gastric Cancer.
Study ID: NCT05188209
Brief Summary: The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with EGFR-positive, HER2-negative, inoperable locally advanced or metastatic gastric cancer.
Detailed Description: Approximately 6054 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003. Patients will receive 2.0 mg/kg dose of MRG003 intravenously every 3 weeks (Q3W) and may receive up to 24 months of MRG003 if there is evidence of clinical benefit to the patients.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Henan Tumor Hospital, Zhengzhou, Henan, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Jinan Central Hospital, Jinan, Shandong, China
Shandong Cancer Hospital, Jinan, Shandong, China
Name: Aiping Zhou, Doctor
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR