A Phase I Study of APX005M Immunotherapy in Pediatric Patients with Persistent or Recurrent Brain Tumors and Newly Diagnosed Brain Stem Glioma

Full Title

PAC Protocol: Phase I Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Pediatric Subjects with Recurrent/Refractory Brain Tumors and Newly Diagnosed Brain Stem Glioma (CIRB)

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy drug APX005M that can be given safely in children with brain tumors that have continued growing or came back despite treatment, as well as those with newly diagnosed diffuse intrinsic pontine glioma (a tumor of the brain stem). APX005M is designed to boost the immune response against cancer by targeting a protein called CD40. It 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 a brain tumor that continued growing or came back despite treatment.
  • Patients with newly diagnosed diffuse intrinsic pontine glioma will be eligible to participate once the first part of the study (for patients with recurrent or persistent brain tumors) is completed.
  • Patients must recover from the serious side effects of prior therapy before entering the study.
  • This study is for patients ages 1 to 21 years of age.

For more information about this study and to inquire about eligibility, please contact Dr. Ira Dunkel at 212-639-2153.

Protocol

18-101

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators