NCT03411915

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Xencor, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroendocrine Tumor
• Gastrointestinal Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	XmAb18087	monoclonal bispecific antibody

Timeline

• Start date: 2018-01-22
• Primary completion: 2021-10-26
• Completion: 2021-10-26
• First posted: 2018-01-26
• Last updated: 2022-05-10

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study