A Phase 2 Study of Safusidenib in People With Glioma

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Full Title

A Phase 2, Multicenter, Open Label, Two Parts Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Patients with Isocitrate Dehydrogenase 1 (IDH1) Mutant Glioma

Purpose

Researchers are seeking the best dose of safusidenib erbumine to treat glioma that came back or keeps growing after treatment. The people in this study have glioma with a mutation (change or variant) in a gene called IDH1. Many gliomas have IDH1 mutations, which help cancer cells survive and grow.

Safusidenib erbumine binds to and blocks certain mutated forms of the IDH1 protein. This blocking may help stop gliomas with the IDH1 mutation from growing, and it may also kill tumor cells. Safusidenib erbumine is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have grade 2 or 3 glioma that came back or keeps growing after 1 or 2 regimens of treatment.
  • Have a glioma with an IDH1 mutation.
  • Have completed prior medical therapies at least 3 weeks before taking safusidenib erbumine (12 weeks since any radiation therapy).
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call the Brain Tumor Hotline at 866-886-9807. You may also call Dr. Thomas Kaley’s office at 212-639-5122.

Protocol

23-199

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05303519