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A Study of MRG002 in the Treatment of HER2-positive/HER2-low Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Cancer.

Locally Advanced Gastric Cancer Clinical Trial

Official title:
An Open-label, Multi-center, Phase II Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of MRG002 in Patients With HER2-positive/HER2-low Locally Advanced or Metastatic Gastric/ Gastroesophageal Junction Cancer.

Clinical Trial Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in patients with HER2-positive /HER2-low locally advanced or metastatic gastric/ gastroesophageal junction cancer.

Clinical Trial Description

There are two cohorts in this study. HER2-positive and HER2-low patients will be allocated to cohort 1 and cohort 2, respectively. When the 20th, 40th, or 60th patient in each cohort completed at least one post-baseline tumor assessment, the Safety Monitoring Committee will review the safety and efficacy of these patients to determine dose selection, enrollment continuation, study population, and sample size. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05141747
Study type Interventional
Source Shanghai Miracogen Inc.
Contact Program Director
Phone 86-21-61637960
Email clinicaltrials@miracogen.com.cn
Status Recruiting
Phase Phase 2
Start date January 19, 2022
Completion date December 2023
View Details
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