Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
Trial Parameters
Brief Summary
This is a phase I study evaluating the safety and pharmacokinetics of MBS301 after intravenous administration in patients with HER-2 positive recurrent or metastatic malignant solid tumors
Eligibility Criteria
Inclusion Criteria: 1. Patients with HER2-positive recurrent or metastatic malignant solid tumor diagnosed by histopathology or cytology. 2. 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. 3. Patients should have measurable lesions or immeasurable lesions (according to RECIST 1.1). 4. ECOG physical condition: 0 or 1 point. 5. Expected survival period exceeds 12 weeks. Exclusion Criteria: 1. 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. 2. Total bilirubin is more than 1.5 ×ULN. 3. 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. 4. Serum creatinine is more than 1.5 × ULN or estimated creatinine clearance \<50 mL/min(according to Cockcroft-Gault). 5. International normalized ratio (INR) is