A Study of XmAb®18087 in Subjects With NET and GIST

Phase 1

Completed

• Conditions: Gastrointestinal Neoplasm; Neuroendocrine Tumor
• Interventions: Biological: XmAb18087

• Registration Number: NCT03411915
• Lead Sponsor: Xencor, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-01-19
• Study Start: 2018-01-22
• Study First Posted: 2018-01-26
• Primary Completion: 2021-10-26
• Study Completion: 2021-10-26
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
XmAb18087	XmAb18087	XmAb18087 administered on days 1, 8, 15, and 22 of each 28-day cycle for a total of 3 cycles

Primary Outcome Measures

Name	Time	Method
Determine the safety and tolerability profile of XmAb18087	84 Days	Treatment-related adverse events as assessed by CTCAE v4.03
Identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087	84 Days	Establishing a safe and tolerable dose of XmAb18087 administered by intravenous (IV) dosing in NET and GIST patients

Trial Locations

Locations (14)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, 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

Emory University; 🇺🇸 Atlanta, Georgia, United States

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States

H. Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of Pennsylvania, Abramson Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

James Cancer Center; 🇺🇸 Columbus, Ohio, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States