A Phase I Study of AMG 596 in Patients with EGFRvIII-positive Glioblastoma

Full Title

Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 in Subjects With Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)

Purpose

The purpose of this study is to assess the safety of the investigational drug AMG 596 in patients with persistent glioblastoma that contains a genetic mutation called EGFRvIII. AMG 596 is a bispecific antibody, which means it can attach to two different proteins: one on the surface of cancer cells and the other on the surface of immune cells.

AMG 596 was designed to attach to cancer cells with the EGFRvIII protein and to immune cells called T cells. Researchers think that AMG 596 may increase the immune system’s ability to fight cancer by activating patients’ T cells to target and kill their tumor cells. AMG 596 is given intravenously (by vein).

Eligibility

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

  • Patient must have grade IV glioblastoma that continues to grow despite prior surgery or radiochemotherapy given after surgery.
  • Patients’ tumors must test positive for the EGFRvIII mutation.
  • Patients may not have had central nervous system bleeding within 6 months of entering the study.
  • This study is for patients age 18 or older.

For more information about this study and to inquire about eligibility, please contact the Brain Tumor Hotline at 866-886-9807.

Protocol

19-097

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators