KN026 in Patients With HER2 Expressing Gastric/Gastroesophageal Junction Cancer
NCT ID: NCT03925974
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2019-06-17
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HER2 overexpression
HER2 IHC 3+ or IHC2+ and ISH+
KN026 10 mg/kg QW
10 mg/kg QW as safety run-in dosage
KN026 20 mg/kg Q2W
20 mg/kg Q2W as target dosage
KN026 30 mg/kg Q3W
30 mg/kg Q3W as another target dosage
HER2 expression
HER2 IHC 2+ISH- or IHC 1+ and ISH+
KN026 10 mg/kg QW
10 mg/kg QW as safety run-in dosage
KN026 20 mg/kg Q2W
20 mg/kg Q2W as target dosage
KN026 30 mg/kg Q3W
30 mg/kg Q3W as another target dosage
Interventions
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KN026 10 mg/kg QW
10 mg/kg QW as safety run-in dosage
KN026 20 mg/kg Q2W
20 mg/kg Q2W as target dosage
KN026 30 mg/kg Q3W
30 mg/kg Q3W as another target dosage
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years and ≤ 75 years, male or female
* Histologically or cytologically documented advanced gastric/gastroesophageal junction cancer HER2 overexpressing: IHC 3+ or IHC 2+ \& ISH+ HER2 expressing: IHC2+ \& ISH- or IHC 1+ \& ISH+
* Received at least one prior standard therapy
* At least one evaluable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function
* LVEF≥ 50% (ECHO)
* Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
* Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures
Exclusion Criteria
* Accepted radiotherapy within 4 weeks before enrollment
* An anthracyclines antibiotic treatment was received exceeding 320 mg/m² 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
* Even with peripheral or central venous nutritional support, unintentional weight loss ≥5% within 1 month before the first medication
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu Alphamab Biopharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Locations
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307 Hospital of PLA
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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KN026-202
Identifier Type: -
Identifier Source: org_study_id
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