drugset / Trial / NCT03411915

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

NCT03411915 ↗

Phase 1 Completed 62 enrolled Xencor, Inc. ICON plc · collab
NaSequentialOpen-labelTreatment

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.

Timeline

Start
2018-01-22
Primary completion
2021-10-26
Completion
2021-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject TIDUTAMAB Monoclonal antibody — —