Back to resultsTrial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer
Primary Purpose
Breast Cancer, Gastric Cancer
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
KN026
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Male or female subject >= 18 years and =<75 years.
- Histologically or cytologically confirmed, locally advanced unresectable or metastatic breast cancer or gastric cancer.
- ECOG score 0 or 1.
- Life expectancy >3 months.
- According to the definition of RECIST1.1, the patient has at least one measurable lesion.
- Adequate organ function prior to start treatment with KN026.
- Able to understand, voluntarily participate and willing to sign the ICF.
- Subjects (women of child-bearing potential and males with fertile female partner) must be willing to use viable contraception method.
Exclusion Criteria:
- Accepted any other anti-tumor drug therapies within 4 weeks before fist dose.
- Accepted radiotherapy within 4 weeks before enrollment(Subjects are eligible, which accepted palliative therapies within 2 weeks before the first dose of KN026 for osseous metastatic and all the AEs recovered).
- An anthracyclines antibiotic treatment, such as doxorubicin (Adriamycin) was received exceeding 300 mg/m² within 90 days before first KN026 dosing, or other equivalent dose antharcyclines.
- Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible.
- Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study.
- Has not recovered (ie, >Grade 1) from AEs except alopecia and anemia.
- History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
- Severe chronic and active infection, need to system antibiosis/antiviral treatment.
- Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage. -
Sites / Locations
- Fudan University Shanghai Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KN026
Arm Description
Outcomes
Primary Outcome Measures
The proportion of patients experiencing dose limiting toxicities.
Secondary Outcome Measures
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest.
Percentage of participants who experience laboratory abnormalities and/or adverse events as defined by CTCAE that are related to treatment
Maximum observed serum concentration (Cmax) of KN026.
Time of Maximum observed serum concentration (Tmax) of KN026.
Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) for KN026.
Serum Half-life (T-HALF) of KN026.
Serum clearance (CL) of KN026.
Volume of distribution at steady state (VSS) of KN026.
Frequency and titer of anti-KN026 antibody.
The proportion of patients with an objective response (partial response or complete response) as defined by RECIST 1.1 criteria.
Progression free survival according to RECIST 1.1 criteria.
Full Information
NCT ID
NCT03619681
First Posted
August 3, 2018
Last Updated
November 16, 2021
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03619681
Brief Title
Trial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer
Official Title
A Single Arm, Open Lable, Dose Escalation Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Preliminary Efficacy of KN026 Monotherapy in Patients With HER2-positive Advanced Malignant Breast and Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a first-in-human (FIH), open-label, phase 1 dose-escalation study of KN026 in subjects with HER2 positive advanced breast and Gastric Cancer. The standard "3 + 3" design was used for dose escalation. There are 5 proposed dose levels which are 5, 10, 15, 20 and 30 mg/kg, but dosing interval may be adjusted during the study (such as QW, OR Q2W, OR Q3W) based on emerging data from this trial and/or from phase 1 trial of KN026 in other country. Dose escalation will continue until the maximum tolerated dose (MTD) is reached or if MTD is not found, dose escalation will continue until the MAD of 20 mg / kg is reached. Dose expansion will carried out in 20 mg/kg Q2W and 30 mg/kg Q3W.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KN026
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KN026
Intervention Description
Patient will be intravenously administrated with one dose of KN026. dosing interval may be adjusted during the study based on emerging data from this trial and/or from other trial.
Primary Outcome Measure Information:
Title
The proportion of patients experiencing dose limiting toxicities.
Time Frame
From screening to up to 28 days
Secondary Outcome Measure Information:
Title
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest.
Time Frame
From screening to up to 112 days
Title
Percentage of participants who experience laboratory abnormalities and/or adverse events as defined by CTCAE that are related to treatment
Time Frame
From screening to up to 112 days
Title
Maximum observed serum concentration (Cmax) of KN026.
Time Frame
Throughout the duration of the study; up to 84 days
Title
Time of Maximum observed serum concentration (Tmax) of KN026.
Time Frame
Throughout the duration of the study; up to 84 days
Title
Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) for KN026.
Time Frame
Throughout the duration of the study; up to 84 days
Title
Serum Half-life (T-HALF) of KN026.
Time Frame
Throughout the duration of the study; up to 84 days.
Title
Serum clearance (CL) of KN026.
Time Frame
Throughout the duration of the study; up to 84 days
Title
Volume of distribution at steady state (VSS) of KN026.
Time Frame
Throughout the duration of the study; up to 84 days
Title
Frequency and titer of anti-KN026 antibody.
Time Frame
Throughout the duration of the study; up to 2 years.
Title
The proportion of patients with an objective response (partial response or complete response) as defined by RECIST 1.1 criteria.
Time Frame
Throughout the duration of the study; up to 2 years.
Title
Progression free survival according to RECIST 1.1 criteria.
Time Frame
Throughout the duration of the study; up to 2 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subject >= 18 years and =<75 years.
Histologically or cytologically confirmed, locally advanced unresectable or metastatic breast cancer or gastric cancer.
ECOG score 0 or 1.
Life expectancy >3 months.
According to the definition of RECIST1.1, the patient has at least one measurable lesion.
Adequate organ function prior to start treatment with KN026.
Able to understand, voluntarily participate and willing to sign the ICF.
Subjects (women of child-bearing potential and males with fertile female partner) must be willing to use viable contraception method.
Exclusion Criteria:
Accepted any other anti-tumor drug therapies within 4 weeks before fist dose.
Accepted radiotherapy within 4 weeks before enrollment(Subjects are eligible, which accepted palliative therapies within 2 weeks before the first dose of KN026 for osseous metastatic and all the AEs recovered).
An anthracyclines antibiotic treatment, such as doxorubicin (Adriamycin) was received exceeding 300 mg/m² within 90 days before first KN026 dosing, or other equivalent dose antharcyclines.
Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible.
Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study.
Has not recovered (ie, >Grade 1) from AEs except alopecia and anemia.
History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
Severe chronic and active infection, need to system antibiosis/antiviral treatment.
Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage. -
Facility Information:
Facility Name
Fudan University Shanghai Cancer Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Trial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer
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