Clinical trial · Interventional
Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| HB1801 | Drug | — | UNRESOLVED |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Recombinant Humanized Bispecific antibody against HER2，KN026 | Drug | — | UNRESOLVED |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KN026+HB1801
- description
- Subjects will receive an intravenous (IV) infusion of KN026 plus HB1801. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurrs first.
- interventionNames
- Drug: Recombinant Humanized Bispecific antibody against HER2，KN026
- Drug: HB1801
- type
- ACTIVE_COMPARATOR
- label
- Trastuzumab + Pertuzumab + Docetaxel
- description
- On Day 1 of each 21-day cycle, patients will receive an intravenous (IV) infusion of Pertuzumab 840 mg loading dose followed by 420 mg per cycle, IV, D1, Q3W, in combination with trastuzumab 8 mg/kg loading dose followed by 6 mg/kg per cycle, IV, D1, Q3W and docetaxel 75 mg/m\^2. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurred first.
- interventionNames
- Drug: Pertuzumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion 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. * No prior systemic chemotherapy and/or HER2-targeted therapy for recurrent or metastatic breast cancer. * Eastern Cooperative Oncology Group (ECOG) physical status score of 0 - 1. * Presence of lesion (RECIST 1.1). * Adequate organ and bone marrow function Key Exclusion Criteria: * Ineligible for any of the agents on the study * Untreated or unstable parenchymal metastases, spinal cord metastases or compression, or carcinomatous encephalitis. * Pregnant or lactating women. * Presence of other circumstances that may interfere with the subject's participation in the study procedures or are inconsistent with the maximum benefit of the subject's participation in the study or affect the results of the study: e.g., history of mental illness, drug or substance abuse, any other disease or condition of clinical significance, etc.
References
Publications (0)
Data not yet available