A phase II open-label multicenter study of ONC201 in adults with recurrent histone H3 K27M mutant glioma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Recurrent High-grade Glioma
  • Age: Between 18 years - 100 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1.Histologically confirmed diagnosis of glioma (any histology, including but not limited to glioblastoma, astrocytoma, oligodendroglioma, malignant glioma, high-grade glioma, etc.) in any tumor sample and presence of histone H3 K27M mutation by a CLIA-approved immunohistochemistry or DNA sequencing test on any glioma tumor sample. 2. Unequivocal evidence of progressive disease on contrast-enhanced brain CT or MRI or have documented recurrent glioma on diagnostic biopsy. 3. Patients can have had any number of prior therapies, however must have had previous therapy with at least radiotherapy.

You may not be eligible for this study if the following are true:

  • 1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ONC201 or its excipients. 2. Current or planned participation in a study of an investigational agent or using an investigational device. 3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.


If you are registered as a volunteer, please log in to contact the study team/express interest in this study.