Actively Recruiting
Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
Led by Shanghai JMT-Bio Inc. · Updated on 2025-05-30
880
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily enrolled and signed informed consent
- Age 18 years or older
- Recurrent or metastatic breast cancer confirmed by tissue tests
- Latest tumor sample confirmed HER2 positive by central lab
- No prior chemotherapy or HER2-targeted therapy for recurrent/metastatic cancer
- ECOG physical status score of 0 or 1
- Presence of measurable lesion by RECIST 1.1 criteria
- Adequate organ and bone marrow function
You will not qualify if you...
- Ineligible for any study treatment agents
- Untreated or unstable brain or spinal cord metastases, spinal cord compression, or carcinomatous encephalitis
- Pregnant or breastfeeding women
- Any other condition or circumstance that may interfere with study participation or affect study results, including mental illness and substance abuse
AI-Screening
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Trial Site Locations
Total: 1 location
1
Clinical Trials Information Group
Beijing, chaoyang, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group Officer
CONTACT
F
fenglin She
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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