Spots Global Cancer Trial Database for ARX788 in Breast Cancer With Low Expression of HER2

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Trial Identification

Brief Title: ARX788 in Breast Cancer With Low Expression of HER2

Official Title: A Single-arm, Single-center Phase II Clinical Study of Recombinant Humanized Anti-HER2 Monoclonal Antibody-AS269 Conjugate (ARX788) in the Treatment of Unresectable and/or Metastatic Breast Cancer With Low Expression of HER2

Study ID: NCT05018676

Conditions

Breast Cancer With Low Expression of HER2

Interventions

ARX788

Study Description

Brief Summary: A Phase 2 Study of ARX788 in unresectable and/or metastatic breast cancer with low expression of HER2.

Detailed Description: A single arm, phase 2 study of ARX788 in unresectable and/or metastatic breast cancer with low expression of HER2. Subjects should received ≥2 lines of systemic chemotherapy regimens for recurrent or metastatic disease, and for HR positive subjects, also need to have received ≥2-line endocrine therapy ± targeted therapy (including neoadjuvant/adjuvant therapy). HER2 low expression is defined as HER2 IHC 1+ or HER2 IHC 2+ and FISH negative. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.