Zanzalintinib for meningioma that has returned or is growing

Who can take part

• Histologically confirmed World Health Organization (WHO) grade 1, 2, or 3 meningioma
• Developed recurrent disease or progressive disease (PD) after receiving standard therapy (for example, surgery and/or radiation) or have been deemed ineligible to receive these therapies. At least 1 prior course of meningioma-directed radiotherapy is required, if not contraindicated
• Radiologically documented progression of any existing tumor (growth > 15% of the bidimensional enhancing tumor within the prior 6 months or appearance of new lesions (including intra and extracranial manifestations)
• For participants treated with external beam radiation, interstitial brachytherapy, or radiosurgery, an interval ≥ 24 weeks must have elapsed from completion of therapy to initiation of treatment
• Measurable disease by RANO meningioma criteria as determined by the investigator, obtained ≤ 14 days prior to initiation of treatment
• Karnofsky performance status (KPS) ≥ 60%
• Demonstrate adequate organ and marrow function within 14 days of treatment initiation

Who cannot take part

• Prior history of hypertensive encephalopathy at any time
• Local therapy (surgery and/or radiation therapy) is indicated per investigator
• Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks or 5 half-lives, whichever is shorter, before initiation of treatment. There is no limit on prior systemic therapies
• Prior Surgery - completed wound healing must occur prior to initiation of treatment; ≥ 8 weeks for major surgery, ≥ 7 days for minor surgery, including stereotactic biopsies
• The participant has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:; Cardiovascular disorders, including uncontrolled hypertension,; Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation,; Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 milliliters [mL]) of red blood within 12 weeks before initiation of treatment or other history of significant bleeding (eg, intracranial hemorrhage/bleeding), or; Other clinically significant disorders
• History of solid organ or allogeneic stem cell transplant; Note: Other protocol defined Inclusion/Exclusion criteria may apply
• Extracranial lesions invading major blood vessels including, but not limited to, inferior vena cava, pulmonary artery, or aorta
• Contraindication to magnetic resonance imaging (MRI)
• Requirement for hemodialysis or peritoneal dialysis