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

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ClinicalTrials.gov Identifier: NCT03411915
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Neuroendocrine Tumor Gastrointestinal Neoplasm Biological: XmAb18087 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: XmAb18087
XmAb18087 administered on days 1, 8, 15, and 22 of each 28-day cycle for a total of 3 cycles
Biological: XmAb18087
monoclonal bispecific antibody




Primary Outcome Measures :
  1. Determine the safety and tolerability profile of XmAb18087 [ Time Frame: 84 Days ]
    Treatment-related adverse events as assessed by CTCAE v4.03

  2. Identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087 [ Time Frame: 84 Days ]
    Establishing a safe and tolerable dose of XmAb18087 administered by intravenous (IV) dosing in NET and GIST patients



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411915


Contacts
Contact: Barbara Hickingbottom, MD 858-480-3413 bhickingbottom@xencor.com
Contact: Mike Lucas 858- 617-6157 mlucas@xencor.com

Locations
United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Stanford Cancer Center Recruiting
Palo Alto, California, United States, 94304
United States, Colorado
University of Colorado, Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern Medicine Recruiting
Chicago, Illinois, United States, 60611
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Ohio
James Cancer Center Recruiting
Columbus, Ohio, United States, 43210
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Xencor, Inc.
ICON plc
Investigators
Study Director: Wayne Saville, MD VP, Oncology Clinical Development, Xencor

Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT03411915     History of Changes
Other Study ID Numbers: XmAb18087-01
DUET-1 ( Other Identifier: Xencor )
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xencor, Inc.:
NET
GIST
DUET-1

Additional relevant MeSH terms:
Neuroendocrine Tumors
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site