Expanded Access to OKN-007 for Patients With Diffuse Midline Glioma, H3 K27-altered

Inclusion criteria

• . Age from \> 12 months to ≤ 18 years of age at the time of enrollment.
• . Diagnosis of diffuse midline glioma, H3 K27-altered according to the WHO 2021 Classification of Tumors of the Central Nervous System diagnostic criteria including diffuse intrinsic pontine glioma (DIPG). In the absence of a pathologically confirmed diagnosis, a grade IV glioma involving the thalamus, hypothalamus, brainstem, cerebellum, midbrain, or spinal cord, or with a pontine epicenter and diffuse involvement of the pons.
• . Patient has completed definitive radiation therapy as part of standard-of-care treatment or was unable to undergo radiation.
• . Karnofsky performance status ≥ 50 for patients ≥ 16 years of age and Lansky performance status ≥ 50 for patients \< 16 years of age; patients who are unable to walk because of paralysis, but who are upright in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
• . Patients must have adequate bone marrow, liver, and renal function:
• . For females of childbearing potential, negative urinary or serum pregnancy test.
• . Patients must be willing to highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration.
• . Toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant

Exclusion criteria