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

Primary Purpose

Neuroendocrine Tumor, Gastrointestinal Neoplasm

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
XmAb18087
Sponsored by
Xencor, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumor focused on measuring NET, GIST, DUET-1

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic
  • City of Hope Medical Center
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
  • Stanford Cancer Center
  • University of Colorado, Anschutz Medical Campus
  • Mayo Clinic
  • H. Lee Moffitt Cancer Center & Research Institute
  • Emory University
  • Northwestern Medicine
  • Dana-Farber Cancer Institute
  • Mayo Clinic
  • Memorial Sloan Kettering Cancer Center
  • James Cancer Center
  • University of Pennsylvania, Abramson Cancer Center
  • MD Anderson Cancer Center
  • University of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XmAb18087

Arm Description

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

Outcomes

Primary Outcome Measures

Determine the safety and tolerability profile of XmAb18087
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
Establishing a safe and tolerable dose of XmAb18087 administered by intravenous (IV) dosing in NET and GIST patients

Secondary Outcome Measures

Full Information

First Posted
January 15, 2018
Last Updated
May 6, 2022
Sponsor
Xencor, Inc.
Collaborators
ICON plc
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1. Study Identification

Unique Protocol Identification Number
NCT03411915
Brief Title
A Study of XmAb®18087 in Subjects With NET and GIST
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
October 26, 2021 (Actual)
Study Completion Date
October 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xencor, Inc.
Collaborators
ICON plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumor, Gastrointestinal Neoplasm
Keywords
NET, GIST, DUET-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XmAb18087
Arm Type
Experimental
Arm Description
XmAb18087 administered on days 1, 8, 15, and 22 of each 28-day cycle for a total of 3 cycles
Intervention Type
Biological
Intervention Name(s)
XmAb18087
Intervention Description
monoclonal bispecific antibody
Primary Outcome Measure Information:
Title
Determine the safety and tolerability profile of XmAb18087
Description
Treatment-related adverse events as assessed by CTCAE v4.03
Time Frame
84 Days
Title
Identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087
Description
Establishing a safe and tolerable dose of XmAb18087 administered by intravenous (IV) dosing in NET and GIST patients
Time Frame
84 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zequn Tang, MD, PhD
Organizational Affiliation
Senior Medical Director, Clinical Development, Xencor
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford Cancer Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado, Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
James Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania, Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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