A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer

Summary

This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.

Timeline

Start

2024-01-29

Primary completion

2026-02

Completion

2026-02

Outcome

Met primary endpoint

release “DualityBio and BioNTech Announce Phase 3 Trial of ADC Candidate BNT323/DB-1303 Met Primary Endpoint of Progression Free Survival in HER2-Positive Metastatic or Unresectable Breast Cancer” dualitybiologics.com ↗

Drugs

Indications