A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma

Inclusion criteria

• . Is ≥ 18 years of age at the time of signing the informed consent.
• . Has histologically confirmed Grade 2 or 3 meningioma.
• . Has failed, is not a candidate for, or has declined standard of care treatment for meningioma. Note: There is no limit on the number of prior systemic therapies.
• . Has measurable disease, as assessed by the investigator. Measurable disease is defined as at least one lesion measuring ≥ 10 mm on perpendicular dimensions by contrast-enhanced MRI performed within 28 days prior to study enrollment.
• . Has progressive disease (PD) per Response Assessment in Neuro-Oncology (RANO) criteria, as assessed by the investigator using axial, contrast-enhanced T1-weighted magnetic resonance imaging (MRI). PD is defined as an increase in size of the measurable primary lesion on imaging by at least 15% in sum of product of target lesions since last treatment or between scans separated by no more than 6 months. The presence of a new lesion would also qualify as PD.
• . Is able to submit historic disease-related imaging from at least 9 months prior to study entry to central imaging vendor (preferably all available disease-related imaging from initial diagnosis onwards).
• . Is able to swallow oral tablets.
• . Has a Karnofsky Performance Status (KPS) of at least 70.

Exclusion criteria