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Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.

NCT05838066 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2025-05-30

No results posted yet for this study

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).

Conditions

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

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

Sponsors & Collaborators

  • Shanghai JMT-Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-23
Primary Completion
2025-07-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05838066 on ClinicalTrials.gov