RC48-C006

NCT03500380 📎

Regimen

Experimental
Disitamab vedotin (RC48) 2.0 mg/kg IV q2w (single-arm phase 2 expansion).
Control
N/A (single-arm)

Population

HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer previously treated with chemotherapy and endocrine therapy (if HR+); Chinese multicenter phase 1b/2 dose-expansion.

Key finding

First pivotal Chinese ADC data showing disitamab vedotin activity in HER2-low MBC prior to DESTINY-Breast04. Supported NMPA approval in gastric cancer and catalyzed further breast RC48 development (RC48-C014 phase 3).

Timeline

    Guideline citations

    • NCCN BREAST