Study on Zanzalintinib for Patients with Returning or Worsening Meningioma

Inclusion Criteria

• Have a confirmed diagnosis of meningioma, which is a type of brain tumor, classified as grade 1, 2, or 3 by the World Health Organization (WHO).
• The tumor must have returned or worsened after standard treatments like surgery or radiation, or the patient must be unable to receive these treatments. At least one prior radiation treatment is required unless it's not safe for the patient.
• The tumor must have grown by more than 15% in size within the last 6 months or new tumors must have appeared, as shown by scans.
• If the patient had radiation treatments, at least 24 weeks must have passed since the last session before starting the study treatment.
• The tumor must be measurable according to specific criteria within 14 days before starting the study treatment.
• The patient must have a Karnofsky performance status (KPS) score of 60% or higher, indicating they can care for themselves with some help.
• The patient must have adequate organ and bone marrow function as shown by tests within 14 days before starting the study treatment.

Exclusion Criteria

• Have a history of severe high blood pressure affecting the brain.
• Have tumors outside the brain that invade major blood vessels like the inferior vena cava or aorta.
• Cannot undergo MRI scans.
• Need local treatments like surgery or radiation as determined by the doctor.
• Have received any cancer treatments, including experimental ones, within 4 weeks or 5 half-lives before starting the study treatment.
• Have not fully healed from any prior surgeries; must wait at least 8 weeks after major surgery or 7 days after minor surgery before starting the study treatment.
• Have uncontrolled or serious illnesses, including:
  • Heart problems like uncontrolled high blood pressure.
  • Digestive issues with a high risk of complications.
  • Significant recent bleeding or history of serious bleeding.
• Require dialysis for kidney problems.
• Have had a solid organ or stem cell transplant.