NCT05018702

ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER2-positive, Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	ARX788	1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle.

Timeline

• Start date: 2021-07-14
• Primary completion: 2022-12-30
• Completion: 2023-06-30
• First posted: 2021-08-24
• Last updated: 2022-06-01

Locations

1 site across 1 country: China