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 | Recruiting Phase 3 DMC

• 1 other identifier: KN026-003
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Free-progression survival (PFS) as evaluated by BIRC (RECIST1.1).

  Up to approximately 4 years

Secondary Outcomes (9)

• PFS (investigator assessment, RECIST1.1)

  Up to approximately 4 years

• Overall survival (OS)

  Up to approximately 4 years

• Objective response rate (ORR)

  Up to approximately 4 years

• Disease control rate (DCR)

  Up to approximately 4 years

• Duration of response (DoR)

  Up to approximately 4 years

Study Arms (2)

KN026+HB1801

EXPERIMENTAL

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: Recombinant Humanized Bispecific antibody against HER2，KN026; Drug: HB1801

Trastuzumab + Pertuzumab + Docetaxel

ACTIVE COMPARATOR

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; Drug: Trastuzumab; Drug: Docetaxel

Interventions

Recombinant Humanized Bispecific antibody against HER2，KN026 DRUG

IV infusion

KN026+HB1801

HB1801 DRUG

IV infusion

KN026+HB1801

Pertuzumab DRUG

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

Trastuzumab + Pertuzumab + Docetaxel

Trastuzumab DRUG

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

Trastuzumab + Pertuzumab + Docetaxel

Docetaxel DRUG

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

Trastuzumab + Pertuzumab + Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

Study Sites (1)

Clinical Trials Information Group

Beijing, chaoyang, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pertuzumab; Trastuzumab; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Clinical Trials Information Group Officer

CONTACT

+86-0311-69085587; ctr-contact@mail.ecspc.com

fenglin She

CONTACT

18301190515; shefenglin@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 1, 2023
• Study Start: July 23, 2023
• Primary Completion: July 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)