TRIAL DETAIL

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

Drug:
Trial Name:
A Study of XmAb®18087 in Subjects With NET and GIST
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
1
Start Date 03/01/2018
Age of Trial (yrs) 1.6
Treatment Phase:
Gleevec-resistant
Drug Category:
SSTR2 + CD3 inhibitor
Strategy:
Immunotherapy
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
XmAb18087-01
Sponsor:
Xencor, Inc.
Patient Contact:
Barbara Hickingbottom, MD 858-480-3413 bhickingbottom@xencor.com Mike Lucas 858- 617-6157 mlucas@xencor.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Intravenous
Trial Notes:
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

Trial Links

Trial Results

Drug Information

Xencor Press Release 2/22/2018
 

Trial Sites

Name
Address
City
State
Zip
Country
1365C Clifton Road
Atlanta
GA
30322
USA
1500 E. Duarte Road
Duarte
CA
91010
USA
1505 Holcombe Blvd.
Houston
TX
77030
USA