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NCT07428616PHASE2Recruiting

A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma

Exelixis

Start Date

5/21/2026

Completion Date

9/30/2029

Summary

The objective of the study is to evaluate efficacy and safety of zanzalintinib in participants with recurrent or progressive meningioma refractory to standard therapies.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * 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 Key Exclusion Criteria: * Prior history of hypertensive encephalopathy at any time. * Extracranial lesions invading major blood vessels including, but not limited to, inferior vena cava, pulmonary artery, or aorta. * Contraindication to magnetic resonance imaging (MRI). * 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. * Requirement for hemodialysis or peritoneal dialysis. * History of solid organ or allogeneic stem cell transplant. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

Zanzalintinib

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Conditions

Meningioma

Locations

University of Alabama

Birmingham, Alabama 35294

United States

Mayo Clinic_Arizona

Phoenix, Arizona 85054

United States

Mayo Clinic_Jacksonville

Jacksonville, Florida 32224

United States

Baptist Health Miami Cancer Institute

Miami, Florida 33176

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Memorial Sloan-Kettering Cancer Center

New York, New York 10065

United States

Mayo Clinic_Rochester

Rochester, New York 55905

United States

Duke University

Durham, North Carolina 27710

United States

UT MD Anderson Cancer Center

Houston, Texas 77030

United States

UT Health San Antonio Mays Cancer Center

San Antonio, Texas 78229

United States

Inova Center for Personalized Health

Fairfax, Virginia 22031

United States

UW Carbone Cancer Center

Madison, Wisconsin 53792

United States