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Trial Title:
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
Condition:
First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Recurrence
Docetaxel
Trastuzumab
Pertuzumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
KN026
Description:
IV infusion
Arm group label:
KN026+HB1801
Intervention type:
Drug
Intervention name:
HB1801
Description:
IV infusion
Arm group label:
KN026+HB1801
Intervention type:
Drug
Intervention name:
Pertuzumab
Description:
840 mg loading dose followed by 420 mg per cycle, D1 Q3W, IV infusion
Arm group label:
Trastuzumab + Pertuzumab + Docetaxel
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
8 mg/kg loading dose followed by 6 mg/kg per cycle, D1 Q3W, IV infusion
Arm group label:
Trastuzumab + Pertuzumab + Docetaxel
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
75 mg/m^2, D1 Q3W, IV infusion
Arm group label:
Trastuzumab + Pertuzumab + Docetaxel
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).
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).
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
July 2023
Completion date:
December 2027
Lead sponsor:
Agency:
Shanghai JMT-Bio Inc.
Agency class:
Industry
Source:
Shanghai JMT-Bio Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05838066
