drugset / Trial / NCT07177950
A Two-cohort Study of SHR-A1811 in the Treatment of HER2-positive Breast Cancer With Brain Metastases
Phase 1/2
Not yet recruiting
51 enrolled
Peking University Cancer Hospital & Institute
Beijing Tiantan Hospital · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a multi-center, open-label, two-cohort study. The purpose of this study is to evaluate the safety, tolerability and efficacy of SHR-A1811 in the treatment of HER2-positive breast cancer with brain and leptomeningeal metastases, and the efficacy and safety of SHR-A1811 in the treatment of HER2-positive breast cancer with brain but without leptomeningeal metastases.
Timeline
- Start
- 2025-09-30
- Primary completion
- 2028-09-30
- Completion
- 2029-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 4.8 mg/kg | Intravenous |
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 15 mg | Intravenous |
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 30 mg | Intravenous |
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 40 mg | Intravenous |