OncoMatch/Clinical Trials/NCT04732065
ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors
Is NCT04732065 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ONC206 for diffuse midline glioma (dmg).
Treatment: ONC206 — This phase I trial studies the effects and best dose of ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that is newly diagnosed or has come back (recurrent) or other recurrent primary malignant CNS tumors. ONC206 is a recently discovered compound that may stop cancer cells from growing. This drug has been shown in laboratory experiments to kill brain tumor cells by causing a so called "stress response" in tumor cells. This stress response causes cancer cells to die, but without affecting normal cells. ONC206 alone or in combination with radiation therapy may be effective in treating newly diagnosed or recurrent diffuse midline gliomas and other recurrent primary malignant CNS tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Intrinsic Pontine Glioma
Glioblastoma
Biomarker criteria
Required: H3-3A K27M
DMG, H3K27 altered
Prior therapy
Must have received: focal radiation therapy — prior therapy
Prior treatment must have included focal radiation therapy
Cannot have received: ONC201
Exception: Prior ONC201 exposure as part of PNOC022 or expanded access programs will be allowed
Patients who participated in trials investigating ONC201 in the upfront setting will not be eligible
Lab requirements
Blood counts
Peripheral absolute neutrophil count (ANC) >= 1.0 g/l. Platelet count >= 100 x 10^9/L (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Kidney function
Serum creatinine < 1.5 ULN based on age and gender
Liver function
Total bilirubin <= 1.5 x ULN for age; in presence of Gilbert's syndrome, total bilirubin < 3 x ULN or direct bilirubin < 1.5 x ULN. ALT <= 3 x ULN. AST <= 3 x ULN.
Peripheral absolute neutrophil count (ANC) >= neutrophil 1.0 g/l. Platelet count >= 100 x 10^9/L (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment). Serum creatinine < 1.5 ULN based on age and gender. Total bilirubin <= 1.5 x upper limit of normal (ULN) for age; in presence of Gilbert's syndrome, total bilirubin < 3 x ULN or direct bilirubin < 1.5 x ULN. Alanine aminotransferase (ALT) <= 3 x ULN. Aspartate aminotransferase (AST) <= 3 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Francisco · San Francisco, California
- Emory University · Atlanta, Georgia
- University of Michigan · Ann Arbor, Michigan
- Children's Hospital of Philadelphia · Philadelphia, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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