Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Recombinant Humanized Bispecific antibody against HER2，KN026, HB1801, Pertuzumab, Trastuzumab.
- Who it may be relevant to
- Registry conditions: First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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).
Detailed description
The purpose of this study is to assess the efficacy and safety of KN026 combined with HB1801 versus trastuzumab combined with pertuzumab and docetaxel as first-line treatment for HER2-positive recurrent or metastatic breast cancer. This study will establish an independent data monitoring committee (IDMC) to conduct safety assessments after approximately 20 subjects in the treatment group complete the first cycle of treatment. During the safety assessment period, the study will continue to enroll subjects, and safety review meetings will be at 1 year of randomization in the first subject. In addition, the IDMC plans to conduct one interim analysis of efficacy during the study period.
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).
Interventions
- Drug Recombinant Humanized Bispecific antibody against HER2，KN026
IV infusion - Drug HB1801
IV infusion - Drug Pertuzumab
840 mg loading dose followed by 420 mg per cycle, D1 Q3W, IV infusion - Drug Trastuzumab
8 mg/kg loading dose followed by 6 mg/kg per cycle, D1 Q3W, IV infusion - Drug Docetaxel
75 mg/m\^2, D1 Q3W, IV infusion
Primary outcome measures
- Free-progression survival (PFS) as evaluated by BIRC (RECIST1.1). [Time frame: Up to approximately 4 years]
Secondary outcome measures (9)
- PFS (investigator assessment, RECIST1.1) [Time frame: Up to approximately 4 years]
- Overall survival (OS) [Time frame: Up to approximately 4 years]
- Objective response rate (ORR) [Time frame: Up to approximately 4 years]
- Disease control rate (DCR) [Time frame: Up to approximately 4 years]
- Duration of response (DoR) [Time frame: Up to approximately 4 years]
- Frequency and severity of TEAE and SAE [Time frame: Up to approximately 4 years]
- Concentration of KN026 in serum [Time frame: Up to approximately 4 years]
- Concentration of HB1801 in serum [Time frame: Up to approximately 4 years]
- Incidence of KN026 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable) [Time frame: Up to approximately 4 years]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Clinical Trials Information Group — Beijing
Identifiers
NCT: NCT05838066 · KN026-003