Expanded Access to ONC201 for Patients with H3 K27M-mutant and/or Midline Gliomas

Are you eligible to participate in this study?

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

  • Conditions:
  • Age: Between 0 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Patient must weigh at least 10kg. 2. Patient meet one or more of the criteria below: Arm A a. Central nervous system tumor that is positive for the H3 K27M mutation (performed in a laboratory with CLIA or equivalent certification); b. Central nervous system tumor involving the thalamus, hypothalamus, basal ganglia, brainstem, cerebellum, cerebellar peduncle, midline cortex, corpus collosum, pineal region, optic tract, or optic chiasm. Arm B c. Diffuse intrinsic pontine glioma (DIPG), defined as tumors with a pontine epicenter and diffuse involvement of the pons. H3 K27M status does not have not be known or positive for this arm.

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

  • 1. Qualifies for participation in an ongoing ONC201 or ONC206 clinical trial. 2. Previously or currently participating in an ONC201 clinical trial or expanded access protocol. 3. Current or planned participation in a study of an investigational agent (including ONC206) or using an investigational device. 4. Evidence of leptomeningeal disease or CSF dissemination of disease.


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