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This is a dose escalation study of CS-1008 (humanized anti-DR5 antibody) to determine the recommended Phase 2 dose and the maximum tolerated dose. Drug will be administered for six weeks and possibly up to 12 weeks depending on response.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS-1008 (humanized anti-DR5 antibody) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the recommended Phase 2 dose |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the pharmacokinetics of CS-1008 administered weekly | ||
| To characterize the immunogenicity of CS-1008 by monitoring for anti-CS-1008 antibodies | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-3300 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C552861 | tigatuzumab |
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| To study potential biomarkers of CS-1008 activity |
| To make preliminary assessments of anti-tumor effects of CS-1008 |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |