Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
NCT ID: NCT05838066
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
880 participants
INTERVENTIONAL
2023-07-23
2027-12-31
Brief Summary
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Detailed Description
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The primary study hypotheses are that the combination of KN026 combined with HB1801 is superior to trastuzumab combined with pertuzumab and docetaxel with respect to: Progression-free Survival (PFS) as assessed by the BIRC per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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KN026+HB1801
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.
Recombinant Humanized Bispecific antibody against HER2，KN026
IV infusion
HB1801
IV infusion
Trastuzumab + Pertuzumab + Docetaxel
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Shanghai JMT-Bio Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trials Information Group
Beijing, chaoyang, China
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Information Group Officer
Role: backup
Other Identifiers
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KN026-003
Identifier Type: -
Identifier Source: org_study_id
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