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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

First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer

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

Inclusion Criteria8

  • 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 Criteria4

  • 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.

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