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This study is to assess the safety, tolerability and pharmacokinetics of single dose and multiple doses of humanized anti-VEGF monoclonal antibody (Sevacizumab) in patients with advanced or metastatic solid tumors. The secondary objective is to explore the preliminary anti-tumor effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevacizumab | Experimental | 2mg/kg、5mg/kg、7.5mg/kg、10mg/kg、12.5mg/kg、or 15mg/kg. d1, d29, d43, d57 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevacizumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57 | |
| tmax | d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57 | |
| AUC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Li, MD, PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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| d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57 |
| t1/2 | d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57 |
| Objective Response Rate (ORR) | d29, d86 |
| Disease Control Rate (DCR) | d29, d86 |