A Study of XmAb®18087 in Subjects With NET and GIST
A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®18087 in Subjects With Advanced Neuroendocrine and Gastrointestinal Stromal Tumors (DUET-1)
2 other identifiers
interventional
62
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2018
Typical duration for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2018
CompletedStudy Start
First participant enrolled
January 22, 2018
CompletedFirst Posted
Study publicly available on registry
January 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2021
CompletedMay 10, 2022
May 1, 2022
3.8 years
January 15, 2018
May 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
XmAb18087
EXPERIMENTALXmAb18087 administered on days 1, 8, 15, and 22 of each 28-day cycle for a total of 3 cycles
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed well differentiated low or intermediate grade (World Health Organization \[WHO\] Grade 1 or 2) NET of pancreatic, gastrointestinal, lung, or undetermined origin that is locally advanced or metastatic and has progressed within the past 12 months
- 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
You may not qualify if:
- Diagnosis of high-grade (WHO Grade 3) or poorly differentiated NET; high-grade neuroendocrine carcinoma; large cell neuroendocrine carcinoma, small cell carcinoma, or mixed small and large cell carcinoma.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xencor, Inc.lead
- ICON plccollaborator
Study Sites (16)
Mayo Clinic
Phoenix, Arizona, 85054, United States
City of Hope Medical Center
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zequn Tang, MD, PhD
Senior Medical Director, Clinical Development, Xencor
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2018
First Posted
January 26, 2018
Study Start
January 22, 2018
Primary Completion
October 26, 2021
Study Completion
October 26, 2021
Last Updated
May 10, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share