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.

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).

Study Overview

• Status: Recruiting
• Conditions: First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer
• Intervention / Treatment: Drug: HB1801; Drug: Pertuzumab; Drug: Trastuzumab; Drug: Docetaxel; Drug: Recombinant Humanized Bispecific antibody against HER2，KN026

Detailed Description

The purpose of this study is to assess the efficacy and safety of KN026 combined with HB1801 versus trastuzumab combined with pertuzumab and docetaxel as first-line treatment for HER2-positive recurrent or metastatic breast cancer. This study will establish an independent data monitoring committee (IDMC) to conduct safety assessments after approximately 20 subjects in the treatment group complete the first cycle of treatment. During the safety assessment period, the study will continue to enroll subjects, and safety review meetings will be at 1 year of randomization in the first subject. In addition, the IDMC plans to conduct one interim analysis of efficacy during the study period.

The primary study hypotheses are that the combination of KN026 combined with HB1801 is superior to trastuzumab combined with pertuzumab and docetaxel with respect to: Progression-free Survival (PFS) as assessed by the BIRC per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

• Study Type: Interventional
• Enrollment (Estimated): 880
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group Officer; Phone Number: +86-0311-69085587; Email: ctr-contact@mail.ecspc.com
• Study Contact Backup: Name: fenglin She; Phone Number: 18301190515; Email: shefenglin@cspc.cn

Study Locations

• China
  • chaoyang
    • Beijing, chaoyang, China
      • Recruiting
      • Clinical Trials Information Group
      • Contact: Clinical Trials Information Group Officer; Phone Number: +86-0311-69085587; Email: ctr-contact@mail.ecspc.com
      • Contact: Clinical Trials Information Group Officer; Phone Number: +86-0311-69085587

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KN026+HB1801; Subjects will receive an intravenous (IV) infusion of KN026 plus HB1801. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurrs first.	Drug: HB1801; IV infusion; Drug: Recombinant Humanized Bispecific antibody against HER2，KN026; IV infusion
Active Comparator: Trastuzumab + Pertuzumab + Docetaxel; On Day 1 of each 21-day cycle, patients will receive an intravenous (IV) infusion of Pertuzumab 840 mg loading dose followed by 420 mg per cycle, IV, D1, Q3W, in combination with trastuzumab 8 mg/kg loading dose followed by 6 mg/kg per cycle, IV, D1, Q3W and docetaxel 75 mg/m^2. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurred first.	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	Up to approximately 4 years
Objective response rate (ORR)	Up to approximately 4 years
PFS (investigator assessment, RECIST1.1)	Up to approximately 4 years
Disease control rate (DCR)	Up to approximately 4 years
Duration of response (DoR)	Up to approximately 4 years
Frequency and severity of TEAE and SAE	Up to approximately 4 years
Concentration of KN026 in serum	Up to approximately 4 years
Concentration of HB1801 in serum	Up to approximately 4 years
Incidence of KN026 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable)	Up to approximately 4 years

Collaborators and Investigators

• Sponsor: Shanghai JMT-Bio Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Skin Diseases; Breast Diseases; Recurrence; Breast Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Trastuzumab; Antibodies; Antibodies, Bispecific; Pertuzumab
• Other Study ID Numbers: KN026-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No