RecruitingPhase 3NCT05838066

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.


Sponsor

Shanghai JMT-Bio Inc.

Enrollment

880 participants

Start Date

Jul 23, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — KN026 and HB1801 — as a first-line treatment for women with HER2-positive breast cancer that has returned or spread to other parts of the body. HER2-positive means the cancer cells have a protein that makes them grow faster, and these drugs specifically target that protein. **You may be eligible if...** - You are 18 or older - You have been diagnosed with HER2-positive breast cancer that is recurrent or metastatic (has spread) - You have not yet received chemotherapy or HER2-targeted therapy for this advanced stage of cancer - You are in good general health (able to carry out normal daily activities) - You have at least one measurable tumor that can be tracked on scans **You may NOT be eligible if...** - You have previously been treated with systemic therapy for metastatic breast cancer - You have active brain metastases (cancer spread to the brain) - You have serious heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRecombinant Humanized Bispecific antibody against HER2,KN026

IV infusion

DRUGHB1801

IV infusion

DRUGPertuzumab

840 mg loading dose followed by 420 mg per cycle, D1 Q3W, IV infusion

DRUGTrastuzumab

8 mg/kg loading dose followed by 6 mg/kg per cycle, D1 Q3W, IV infusion

DRUGDocetaxel

75 mg/m\^2, D1 Q3W, IV infusion


Locations(1)

Clinical Trials Information Group

Beijing, chaoyang, China

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NCT05838066