A Phase I Study of XmAb18087 Immunotherapy to Treat Advanced Neuroendocrine Tumors

Full Title

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)

Purpose

The purpose of this study is to find the highest dose of an investigational immunotherapy drug called XmAb18087 that can be given safely in patients with advanced neuroendocrine tumors that cannot be surgically removed and/or have spread to other parts of the body. XmAb18087, is a “bispecific antibody,” designed to bind to two different proteins at the same time: one on the surface of cancer cells and the other on the surface of T cells (which play a key role in the immune system’s fighter response). Researchers believe that the drug’s method of action may increase the immune system’s ability to fight cancer cells by activating a patient’s own cells to kill the tumor.

XmAb18087 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an inoperable or metastatic neuroendocrine or gastrointestinal stromal tumor (GIST) that has continued to grow despite prior therapy with available standard treatments. Examples of neuroendocrine tumors include those of the lung and pancreas.
  • At least 2 weeks must pass between the completion of prior therapies and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 12 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Diane Reidy-Lagunes at 646-888-4185.

Protocol

18-266

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators