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This is a Phase I, open label, dose-escalation study of MetMAb administered by intravenous (IV) infusion in patients with advanced solid malignancies that are refractory to or for which there is no standard of care. The study consists of a dose-escalation stage, an expansion stage testing MetMAb at the recommended Phase II dose (RP2D), and a dose-escalation stage testing the combination of MetMAb, at two different doses with bevacizumab at a recommended dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage I | Experimental |
| |
| Stage II | Experimental |
| |
| Stage III | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Drug | Repeating intravenous dose |
| |
| MetMAb |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of MetMAb alone or in combination with bevacizumab will be assessed (frequency and nature of dose-limiting toxicities; nature, severity, and relatedness of adverse events; changes in vital signs and clinical laboratory parameters) | Length of study |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response, defined as a complete or partial response confirmed ≥4 weeks after initial documentation | Length of study | |
| Duration of objective response | Length of study | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Premal Patel, M.D. | Genentech, Inc. | Study Director |
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| Drug |
Repeating escalating intravenous dose |
|
| MetMAb | Drug | Repeating intravenous dose |
|
| Progression-free survival |
| Length of study |
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C584058 | onartuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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