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| ID | Type | Description | Link |
|---|---|---|---|
| DUET-1 | Other Identifier | Xencor |
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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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This is a Phase 1, multiple dose, ascending dose escalation study; to define a MTD/RD and regimen consisting of a first "priming" dose and escalated subsequent doses of XmAb18087; to describe safety and tolerability; to assess PK and immunogenicity; and to preliminarily assess anti-tumor activity of XmAb18087 in subjects with advanced NET or GIST.
The study will enroll dosing cohorts to establish a MTD/RD and regimen in subjects with advanced NET or GIST, then enroll additional subjects into separate NET and GIST expansion cohorts to collect additional data on safety and potential efficacy of XmAb18087.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XmAb18087 | Experimental | XmAb18087 administered on days 1, 8, 15, and 22 of each 28-day cycle for a total of 3 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XmAb18087 | Biological | monoclonal bispecific antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the safety and tolerability profile of XmAb18087 | Treatment-related adverse events as assessed by CTCAE v4.03 | 84 Days |
| Identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087 | Establishing a safe and tolerable dose of XmAb18087 administered by intravenous (IV) dosing in NET and GIST patients | 84 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zequn Tang, MD, PhD | Senior Medical Director, Clinical Development, Xencor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| City of Hope Medical Center |
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| Duarte |
| California |
| 91010 |
| United States |
| Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | 90048 | United States |
| Stanford Cancer Center | Palo Alto | California | 94304 | United States |
| University of Colorado, Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern Medicine | Chicago | Illinois | 60611 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| James Cancer Center | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania, Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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