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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.

Primary Purpose

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

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
KN026
HB1801
Pertuzumab
Trastuzumab
Docetaxel
Sponsored by
Shanghai JMT-Bio Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    KN026+HB1801

    Trastuzumab + Pertuzumab + Docetaxel

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 20, 2023
    Last Updated
    April 20, 2023
    Sponsor
    Shanghai JMT-Bio Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05838066
    Brief Title
    Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
    Official Title
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    July 2026 (Anticipated)
    Study Completion Date
    December 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai JMT-Bio Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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).
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    880 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    KN026+HB1801
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Trastuzumab + Pertuzumab + Docetaxel
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    KN026
    Intervention Description
    IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    HB1801
    Intervention Description
    IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Pertuzumab
    Intervention Description
    840 mg loading dose followed by 420 mg per cycle, D1 Q3W, IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Trastuzumab
    Intervention Description
    8 mg/kg loading dose followed by 6 mg/kg per cycle, D1 Q3W, IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Docetaxel
    Intervention Description
    75 mg/m^2, D1 Q3W, IV infusion
    Primary Outcome Measure Information:
    Title
    Free-progression survival (PFS) as evaluated by BIRC (RECIST1.1).
    Time Frame
    Up to approximately 4 years
    Secondary Outcome Measure Information:
    Title
    PFS (investigator assessment, RECIST1.1)
    Time Frame
    Up to approximately 4 years
    Title
    Overall survival (OS)
    Time Frame
    Up to approximately 4 years
    Title
    Objective response rate (ORR)
    Time Frame
    Up to approximately 4 years
    Title
    Disease control rate (DCR)
    Time Frame
    Up to approximately 4 years
    Title
    Duration of response (DoR)
    Time Frame
    Up to approximately 4 years
    Title
    Frequency and severity of TEAE and SAE
    Time Frame
    Up to approximately 4 years
    Title
    Concentration of KN026 in serum
    Time Frame
    Up to approximately 4 years
    Title
    Concentration of HB1801 in serum
    Time Frame
    Up to approximately 4 years
    Title
    Incidence of KN026 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable)
    Time Frame
    Up to approximately 4 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Clinical Trials Information Group Officer
    Phone
    +86-0311-69085587
    Email
    ctr-contact@mail.ecspc.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    fenglin She
    Phone
    18301190515
    Email
    shefenglin@cspc.cn

    12. IPD Sharing Statement

    Learn more about this trial

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

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