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

Neuroendocrine Tumor Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411915
• Other study ID #: XmAb18087-01
• Secondary ID: DUET-1
• Status: Completed
• Phase: Phase 1
• Start date: January 22, 2018
• Est. completion date: October 26, 2021

Study information

• Verified date: May 2022
• Source: Xencor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 26, 2021
• Est. primary completion date: October 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasm
• Gastrointestinal Neoplasms
• Neuroendocrine Tumor
• Neuroendocrine Tumors

Intervention

Biological:
• XmAb18087
monoclonal bispecific antibody

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Colorado, Anschutz Medical Campus	Aurora	Colorado
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern Medicine	Chicago	Illinois
United States	James Cancer Center	Columbus	Ohio
United States	City of Hope Medical Center	Duarte	California
United States	MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic	Jacksonville	Florida
United States	Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute	Los Angeles	California
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Stanford Cancer Center	Palo Alto	California
United States	University of Pennsylvania, Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Xencor, Inc.	ICON plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the safety and tolerability profile of XmAb18087	Treatment-related adverse events as assessed by CTCAE v4.03	84 Days
Primary	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