Status:
UNKNOWN
KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer
Lead Sponsor:
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Conditions:
Breast Cancer
Gastric/Gastroesophageal Junction Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03847168
Start Date
June 18 2019
End Date
December 31 2022
Last Update
November 17 2021
Active Locations (1)
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1
Greenville Health System Center Institute
Greenville, South Carolina, United States, 29605