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A Study of MRG002 in the Treatment of Patients With HER2-low Locally Advanced or Metastatic Breast Cancer (BC)

Advanced or Metastatic Breast Cancer Clinical Trial

Official title:
A Multicenter, Non-randomized, Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG002 in the Treatment of Patients With HER2-low Locally Advanced or Metastatic Breast Cancer (BC)

Clinical Trial Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-low locally advanced or metastatic BC.

Clinical Trial Description

The study will be conducted in two parts. The first part is efficacy exploration and the second part is efficacy verification. During the course of efficacy exploration, 33 subjects will be enrolled to preliminarily evaluate the safety and efficacy of MRG002. The second part will be adjusted according to the result of the first part. 29 subjects are planned to be enrolled. Considering the dropout rate of 10%, approximately 33 subjects are planned to be enrolled. A total of 66 subjects are planned to be enrolled in efficacy exploration and verification. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04742153
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 May 13, 2021
Completion date February 2023
View Details
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