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This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI9090 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI9090 | Biological | MEDI9090 will be administered by IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects reporting infusion related reactions | First dose of study medication through 30 days after the first dose of study medication | |
| Number of subjects that develop changes in detectable antidrug antibodies to MEDI9090 | First dose of study medication through 6 months after the last dose of study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Individual MEDI9090 concentrations | First dose of study medication through 3 months after the last dose of study medication | |
| Number of subjects reporting adverse events | Screening through 3 months after last dose of study medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MedImmune LLC | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Scottsdale | Arizona | 85258 | United States | ||
| Research Site |
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
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| Durvalumab |
| Biological |
Durvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090. |
|
| Number of subjects reporting serious adverse events | Screening through 3 months after the last dose of study medication |
| Number of subjects with vital sign abnormalities reported as adverse events | Screening through 3 months after the last dose of study medication |
| Number of subjects with ECG abnormalities reported as adverse events | Screening through 3 months after the last dose of study medication |
| Los Angeles |
| California |
| 90025 |
| United States |
| Research Site | Denver | Colorado | 80218 | United States |
| Research Site | Huntersville | North Carolina | 28078 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | KÅtoku | 135-8550 | Japan |
| Research Site | Sapporo | 003-0804 | Japan |
| Research Site | Sunto-gun | 411-8777 | Japan |