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| Name | Class |
|---|---|
| Agensys, Inc. | INDUSTRY |
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This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety and tolerability of ASG-5ME and identify the maximum tolerated dose in patients with pathologically confirmed metastatic pancreatic adenocarcinoma, and to evaluate safety and tolerability in patients with relapsed or refractory gastric adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ASG-5ME |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASG-5ME | Drug | 0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and laboratory abnormalities | Through 1 month after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Best clinical response | Every 2 months | |
| Overall and progression-free survival | Every month until death or study closure | |
| Concentrations of ASG-5ME and metabolites in blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Whiting, PharmD, BCOP | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TGen Clinical Research Service at Scottsdale Healthcare | Scottsdale | Arizona | 85259 | United States | ||
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C583373 | ASG-5ME |
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| Through 1 month after last dose |
| Incidence of antitherapeutic antibodies in blood | Through 1 month after last dose |
| University of California at San Francisco |
| San Francisco |
| California |
| 94115 |
| United States |
| University of Chicago | Chicago | Illinois | 60637-1470 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Texas Oncology - Baylor Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | United States |
| Seattle Cancer Care Alliance / University of Washington | Seattle | Washington | 98109-1023 | United States |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |