Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

All Drugs and Chemicals

Antibodies

Immunoglobulins

On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg calculated based on the actual body weight

MRG003

Program Director

Wenhua Xue, Secretary

Qingxia Fan, Doctor

Baoxia He, Director

Ying Liu, Doctor

Fang Xu, Secretary

Xinjun Liang, Doctor

Xiaoran Zhang, Secretary

Meili Sun, Doctor

Zhehai Wang, Secretary

Changzheng Li, Doctor

Aiping Zhou, Doctor

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.

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.

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer.

A Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in EGFR-Positive, HER2-Negative Advanced Gastric Cancer.

ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by Independent Review Committee (IRC) according to RECIST v1.1.

Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.

ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.

PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.

DCR is defined as the proportions of patients achieving CR, PR, and stable disease (SD) after treatment.

OS is defined as the duration from the start of treatment to death of any cause.

Area under the curve up to the last validated measurable plasma concentration

The proportion of patients with positive ADA immunogenicity results.

Spots Global Cancer Trial Database for advanced or metastatic gastroesophageal junction carcinoma