Meningioma Clinical Trials

• Age

• Is ≥ 18 years of age at the time of signing the informed consent.

• Type of Participant and Disease Characteristics

• 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.

• Has laboratory test results meeting the following parameters within 14 days before the start of study intervention:

∙ Absolute neutrophil count ≥ 1.0 × 109/L and platelets ≥ 75 × 109/L.

‣ Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (participants with Gilbert's syndrome may be included with total bilirubin \> 1.5 × ULN if direct bilirubin is ≤ 1.5 × ULN).

‣ Aspartate (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN. Note: For participants with documented baseline liver metastasis, the following limits will apply: ≤ 5 × ULN for transaminase.

‣ Creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft Gault equation (or estimated glomerular filtration rate \[eGFR\] \> 60 mL/min/1.73 m2) or serum creatinine ≤ 1.5 × ULN.

⁃ Has an expected survival of at least 12 weeks, as predicted by the physician.

⁃ Is able to submit at least 10 (preferably ≥ 15 slides, if available) unstained formalin-fixed paraffin-embedded (FFPE) slides or a tissue block with sufficient material for \

• 15 slides from participant's tumor tissue to the sponsor.

⁃ Has had an MRI within 28 days before the start of study intervention, with the corticosteroid dose stable or decreasing at least 5 days prior to the scan.

⁃ Sex and Contraceptive/Barrier Requirements

⁃ Agrees to the following based on sex assigned at birth: is not of child-bearing potential or agrees to use appropriate contraception, as defined in protocol, for males and females.