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.

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).

ClinicalTrials.gov IDNCT05838066

PhasePHASE3

Enrollment880

SponsorShanghai JMT-Bio Inc.

Age18 Years and older

SexALL

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Conditions studied

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

About this study

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 outcomes

Free-progression survival (PFS) as evaluated by BIRC (RECIST1.1). (Up to approximately 4 years)

Eligibility information

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.

Study locations

Clinical Trials Information Group, Beijing, chaoyang China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-05.