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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mg/kg Onartuzumab (MetMAb) | Experimental |
| |
| 15 mg/kg Onartuzumab (MetMAb) | Experimental |
| |
| 30 mg/kg Onartuzumab (MetMAb) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 mg/kg Onartuzumab (MetMAb) | Drug | 4 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 1 year | |
| Total exposure of MetMAb, as measured by area under the concentration-time curve (AUC) | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anti-therapeutic antibodies against MetMAb | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | 100142 | China | |||
| the First Hospital of Jilin University |
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| 15 mg/kg Onartuzumab (MetMAb) | Drug | 15 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks. |
|
| 30 mg/kg Onartuzumab (MetMAb) | Drug | 30 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks. |
|
| Changchun |
| 130021 |
| China |
| Sun Yet-sen University Cancer Center | Guangzhou | 510060 | China |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C584058 | onartuzumab |
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