This phase I study will examine the pharmacokinetics and safety of Onartuzumab (MetMAb) in chinese patients with locally advanced or metastatic solid tumors. Patients will be divided into 3 cohorts, which will each be given a different dose of MetMAb. The cohorts will be treated sequentially, starting with the lowest dose. MetMAb will be administered intravenously every 3 weeks. Patients may be treated for up to 16 cycles (21 days each) or 1 year, whichever occurs first, in the absence of disease progression.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
4 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
15 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
30 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
Beijing Cancer Hospital
Beijing, China
the First Hospital of Jilin University
Changchun, China
Sun Yet-sen University Cancer Center
Guangzhou, China
Incidence of adverse events
Time frame: Up to 1 year
Total exposure of MetMAb, as measured by area under the concentration-time curve (AUC)
Time frame: Up to 1 year
Incidence of anti-therapeutic antibodies against MetMAb
Time frame: Up to 1 year
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