Status:
COMPLETED
A Study of XmAb®18087 in Subjects With NET and GIST
Lead Sponsor:
Xencor, Inc.
Collaborating Sponsors:
ICON plc
Conditions:
Neuroendocrine Tumor
Gastrointestinal Neoplasm
Eligibility:
All Genders
12+ years
Phase:
PHASE1
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2021
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03411915
Start Date
January 22 2018
End Date
October 26 2021
Last Update
May 10 2022
Active Locations (16)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
City of Hope Medical Center
Duarte, California, United States, 91010
3
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
4
Stanford Cancer Center
Palo Alto, California, United States, 94304