Spots Global Cancer Trial Database for ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases

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Trial Identification

Brief Title: ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases

Official Title: A Prospective, Single-arm, Single-center Phase II Clinical Study of Recombinant Humanized Anti-HER2 Monoclonal Antibody-AS269 Conjugate (ARX788) in the Treatment of HER2-positive Breast Cancer Patients With Brain Metastases

Study ID: NCT05018702

Conditions

HER2-positive, Metastatic Breast Cancer

Interventions

ARX788

Study Description

Brief 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).

Detailed 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.