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Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
Sponsor: Shanghai JMT-Bio Inc.
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).
Official title: A Randomized, Controlled, Open-label, Multicenter, Phase Ш Clinical Study of the Efficacy and Safety of KN026 in Combination With HB1801 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
880
Start Date
2023-07-23
Completion Date
2027-12-31
Last Updated
2025-05-30
Healthy Volunteers
No
Interventions
Recombinant Humanized Bispecific antibody against HER2，KN026
IV infusion
HB1801
IV infusion
Pertuzumab
840 mg loading dose followed by 420 mg per cycle, D1 Q3W, IV infusion
Trastuzumab
8 mg/kg loading dose followed by 6 mg/kg per cycle, D1 Q3W, IV infusion
Docetaxel
75 mg/m\^2, D1 Q3W, IV infusion
Locations (1)
Clinical Trials Information Group
Beijing, chaoyang, China