Study on JZP3507 for Treating Recurrent Grade 2 or 3 Meningioma

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of Grade 2 or 3 meningioma.
• Have tried standard treatments for meningioma without success, or are not candidates for them.
• Have at least one tumor that can be measured by MRI.
• Have a tumor that is growing, as shown by recent MRI scans.
• Be able to provide past imaging scans of the disease.
• Be able to swallow tablets.
• Have a Karnofsky Performance Status (KPS) of at least 70, indicating the ability to care for oneself.
• Have certain blood test results within normal ranges.
• Have an expected survival of at least 12 weeks.
• Be able to provide a sample of tumor tissue for analysis.
• Have had an MRI within 28 days before starting the study, with stable or decreasing steroid use.
• Agree to use effective contraception if of childbearing potential.

Exclusion Criteria

• Have an allergy to JZP3507 or its ingredients.
• Have active heart disease.
• Have another cancer that is progressing or has needed treatment in the past 2 years, except for certain skin cancers or cervical cancer.
• Have an active infection needing treatment.
• Have received certain cancer treatments or medications within specific timeframes before starting the study.
• Have uncontrolled health issues or conditions that might interfere with the study.
• Have previously taken JZP3507 or dordaviprone.
• Have certain types of meningiomas, such as those affecting the optic nerve or outside the brain.
• Have more than three measurable tumors.