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

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

Gastrointestinal Stromal Tumor

Active, not recruiting

1

Start Date 03/01/2018

Age of Trial (yrs) 6.2

Gleevec-resistant

SSTR2 + CD3 inhibitor

Immunotherapy

Specifically GIST plus other cancers

XmAb18087-01

Xencor, Inc.

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

Intravenous

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.

Inclusion Criteria:
GIST subjects must have previously received all FDA-approved therapies (imatinib mesylate, sunitinib malate, and regorafenib) for which they are eligible