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

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).

Trial Details

NCT ID
NCT05838066
Phase
PHASE3
Sponsor
Shanghai JMT-Bio Inc.
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Recombinant Humanized Bispecific antibody against HER2，KN026
  • HB1801
  • Pertuzumab
  • Trastuzumab
  • Docetaxel
Locations (sample)
  • Beijing, chaoyang, China|39.9075,116.39723

Key Eligibility Criteria

  • Voluntarily enrolled in this study and signed an informed consent form (ICF).
  • Age ≥ 18 years.
  • Recurrent or metastatic breast cancer confirmed by histology and/or cytology.
  • Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing.

For full eligibility, visit ClinicalTrials.gov.

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