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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.

StatusRecruiting
PhasePhase 3
Started2023-07-23
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 30, 2025 (before its estimated July 31, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-05-26
Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Contacts/Locations, IPDSharing v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-07→2025-07-31
Completion date2027-12→2027-12-31
Start dateestimated 2023-07→confirmed 2023-07-23
Study sites0→1
InterventionsDocetaxel (Drug), HB1801 (Drug), KN026 (Drug), Pertuzumab (Drug), Trastuzumab (Drug)→Docetaxel (Drug), HB1801 (Drug), Pertuzumab (Drug), Recombinant Humanized Bispecific antibody against HER2，KN026 (Drug), Trastuzumab (Drug)
2023-04-20
Original filing
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 Number NCT05838066
Lead Sponsor Shanghai JMT-Bio Inc.
Conditions First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer
Enrollment 880 participants
Start Date 2023-07-23
Primary Completion 2025-07-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-30