This is an open-label, two arm study. The trial will enroll a total of up to 36 patients. Arm A will enroll up to a total of 6 evaluable patients and Arm B will enroll up to a total of 30 evaluable patients. Arm A will explore the intra-tumoral ONC201 concentrations and pharmacodynamic activity in adult EGFR-low glioblastoma patients. Arm B will determine the radiographic efficacy of ONC201 in adult recurrent EGFR-low glioblastoma patients. All patients will be treated with oral ONC201 (625 mg) twice weekly, 2 consecutive days on and 5 days off per week schedule.
Description: intra-tumoral ONC201 concentrations in adult EGFR-low glioblastoma patients.Measure: Intra-tumoral ONC201 concentrations Time: 11 Days
Description: Objective Response Rate of ONC201 in adult recurrent EGFR-low glioblastoma patients.Measure: Objective Response Rate Time: 6 months
There is one SNP
2. Patient has a known histone H3 K27M mutation. --- K27M ---