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Clinical Trial Summary

A Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients whose Disease is resistant or refractory to Tyrosine kinase inhibitors (TKI).


Clinical Trial Description

This is an open-label, single arm, phase 2 study of ARX788 in HER2-positive, metastatic breast cancer patients whose disease is resistant or refractory to TKI. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion. In this study, Simon's two-stage design is used. Subjects received treatment until disease progression, intolerable toxicity, withdrawal from the study, or discontinuation judged by the investigator. Drug efficacy and safety data will be collected. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05018702
Study type Interventional
Source Fudan University
Contact Ting Li
Phone 86-18121299346
Email cinderellaliting@126.com
Status Recruiting
Phase Phase 2
Start date July 14, 2021
Completion date June 30, 2023