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This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors. This is the first study of hCBE-11 in humans and is designed to determine the safety and how well patients tolerate this investigational drug. The study duration is two years with treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and long-term follow-up contact every 3 months thereafter.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hCBE-11 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To define the recommended Phase II dose of hCBE-11 | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tucson | Arizona | 85724-5024 | United States | ||
| Research Site |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Aurora |
| Colorado |
| 80045 |
| United States |
| Research Site | Philadelphia | Pennsylvania | 19111-2497 | United States |