Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
62 participants
INTERVENTIONAL
2018-01-22
2021-10-26
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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XmAb18087
XmAb18087 administered on days 1, 8, 15, and 22 of each 28-day cycle for a total of 3 cycles
XmAb18087
monoclonal bispecific antibody
Interventions
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XmAb18087
monoclonal bispecific antibody
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed GIST that is locally advanced or metastatic
* NET and GIST tumors must be unresectable
* NET subjects must have progressed on or been ineligible for treatment with somatostatin analogues (SSA) and at least one other FDA-approved targeted therapy (everolimus or sunitinib).
* GIST subjects must have previously received all FDA-approved therapies (imatinib mesylate, sunitinib malate, and regorafenib) for which they are eligible
* Must have disease measurable by RECIST 1.1 criteria using either computed tomography (CT) or magnetic resonance imaging (MRI) scan
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
* Subjects currently receiving anti-cancer therapies (other than SSAs, which may continue).
* Subjects who have received anti-cancer therapies within 2 weeks of the start of study drug (including chemotherapy, radiation therapy, immunotherapy, etc.).
* Must not be experiencing a Grade 3 or 4 toxicity from previous anti-cancer treatment
* Must not be receiving other anti-cancer therapies (except somatostatin analogues, which may be allowed)
* Must not have poorly controlled diabetes mellitus, known central nervous system involvement by malignant disease or insufficient bone marrow, renal, or hepatic function
12 Years
ALL
No
Sponsors
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ICON plc
INDUSTRY
Xencor, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Zequn Tang, MD, PhD
Role: STUDY_DIRECTOR
Senior Medical Director, Clinical Development, Xencor
Locations
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Mayo Clinic
Phoenix, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
Stanford Cancer Center
Palo Alto, California, United States
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern Medicine
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
James Cancer Center
Columbus, Ohio, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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DUET-1
Identifier Type: OTHER
Identifier Source: secondary_id
XmAb18087-01
Identifier Type: -
Identifier Source: org_study_id
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