A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC

Inclusion Criteria

• •Written informed consent obtained prior to performing any protocol-related procedures
• •Male or female, age ≥ 18 years old at the time of screening.
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •Subject has histologically confirmed HER2 positive metastatic breast cancer.
• •Have received standard anti-HER2 directed therapy in the metastatic setting (mandatory to have trastuzumab), regardless of having received (neo)adjuvant anti-HER2 therapy or not.
• •Have received treatment with no more than four lines of therapy overall in the metastatic setting (including anti-HER2 targeted therapy or chemotherapy) and must have disease progressed on or after, the most recent line of therapy. per RECIST 1.1.
• •Previous adverse events associated with anti-tumor therapy have been recovered to NCI-CTCAE v4.03 Grade ≤1 (except NCI-CTCAE v4.03 Grade ≤2 alopecia, stable sensory neuropathy, or stabilized electrolyte disturbance after fluid transfusion).
• •Subject has life expectancy ≥12 weeks.
• •Subject has no supportive therapy of blood transfusion or growth factor within 4 weeks before dosed and has adequate organ functions
• •Subject has a negative test result of pregnancy test at screening.