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

NCT03411915 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2022-05-10

No results posted yet for this study

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

BIOLOGICAL

XmAb18087

monoclonal bispecific antibody

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Xencor, Inc.

    lead INDUSTRY

Principal Investigators

  • Zequn Tang, MD, PhD · Senior Medical Director, Clinical Development, Xencor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-22
Primary Completion
2021-10-26
Completion
2021-10-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03411915 on ClinicalTrials.gov