Trial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer

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. -