Overview

Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.

Status:
Not yet recruiting

Trial end date:
2027-12-01

Target enrollment:

Participant gender:

Summary

This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with HER2-positive recurrent or metastatic breast cancer. The statistical assumption for this study is superiority. The primary study endpoint was PFS as assessed by Blinded Independ Review Committee (BIRC).

Phase:

Phase 3

Details

Lead Sponsor:

Shanghai JMT-Bio Inc.

Treatments:

Docetaxel
Pertuzumab
Trastuzumab