Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor

Inclusion criteria

• Patients with HER2-positive recurrent or metastatic malignant solid tumor diagnosed by histopathology or cytology.
• Patients with any types of malignant solid tumors who have progressed despite standard therapy or are intolerant of standard therapy, or for which no standard therapy exists.
• Patients should have measurable lesions or immeasurable lesions (according to RECIST 1.1).
• ECOG physical condition: 0 or 1 point.
• Expected survival period exceeds 12 weeks.

Exclusion criteria

• Absolute neutrophils count (ANC) is less than1.5×109/L and/or blood platelets less than 100 ×109/L and/or hemoglobin less than 9g/dL.
• Total bilirubin is more than 1.5 ×ULN.
• Patients without hepatic metastasis, ALT or AST is more than 1.5 ×ULN; Patients with hepatic metastasis, ALT or AST is more than 3 ×ULN.
• Serum creatinine is more than 1.5 × ULN or estimated creatinine clearance <50 mL/min(according to Cockcroft-Gault).
• International normalized ratio (INR) is more than 1.5 × ULN or activated partial thromboplastin time (APTT) is more than 1.5 × ULN.
• Patient has prior treated with anthracyclineswhich accumulated dose is equivalent to adriamycin≥360mg/m2.
• Patient has been experienced toxic reactions after previous anticancer therapy and has not recovered to Grade 0 or Grade 1 (except for hair loss).
• Known a history with brain metastasis.
• Have a history of liver disease of clinical significance.
• Known to be human immunodeficiency virus (HIV) positive.