A Phase I Study of AG-881 to Treat Advanced Solid Tumors, including Gliomas, that Contain Mutated IDH1 or IDH2

Full Title

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-881 in Patients with Advanced Solid Tumors, Including Gliomas, with an IDH1 and/or IDH2 Mutation

Purpose

The purpose of this study is to find the highest dose of an investigational drug called AG-881 that can be given safely in patients with advanced solid tumors, including gliomas, that contain a mutated form of a protein called IDH and continued to grow despite prior therapy. There are two types of IDH, called IDH1 and IDH2. Abnormal IDH1 and IDH2 cause too much of a substance called 2-HG to be produced, which may make some cancers grow.

AG-881 blocks mutated forms of the IDH1 and IDH2 proteins and may reduce 2-HG levels in diseased cells to normal levels. It is taken orally (by mouth).

Eligibility

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

  • Patients must have an advanced malignant solid tumor, such as glioma, which has continued to grow or has come back despite prior radiation therapy and/or chemotherapy, or for which no standard therapy exists.
  • Patients' tumors must contain an abnormal form of the IDH gene. Doctors will test patients' tumors for this mutation if they haven't been tested already.
  • At least 3 weeks must pass between the completion of prior therapy and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ingo Mellinghoff at 866-886-9807.

Protocol

16-003

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Locations