Back to resultsKN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer
Primary Purpose
Breast Cancer, Gastric/Gastroesophageal Junction Cancer
Status
Active
Phase
Phase 1
Locations
United States
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
- Histologically/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
- An anthracyclines antibiotic treatment 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
- 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
- Greenville Health System Center Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KN026
Arm 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.
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
Maximum observed serum concentration (Cmax) of KN026
Time of Maximum observed serum concentration (Tmax) 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
NCT03847168
First Posted
February 18, 2019
Last Updated
November 16, 2021
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03847168
Brief Title
KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer
Official Title
Phase I Study of KN026 in HER2 Expressing Breast Cancer, Astric/Gastroesophageal Junction Cancer and Other Locally Advanced/Metastatic Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 18, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (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
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is an 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 3 proposed dose levels which are 10, 15, and 20 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Gastric/Gastroesophageal Junction 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
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KN026
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
KN026
Intervention Description
Patient will be intravenously administrated with one dose of KN026 every week or every other week.
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 196 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
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
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subject >= 18 years
Histologically/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
An anthracyclines antibiotic treatment 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
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
Greenville Health System Center Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
12. IPD Sharing Statement
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KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer
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