A Study of Zanzalintinib for Recurrent or Progressive Meningioma
This study is testing a drug called zanzalintinib in people with meningioma that has come back or gotten worse after standard treatments like surgery or radiation. You might be able to join if you are 18 or older, have a confirmed meningioma (a type of brain tumor), and your tumor has progressed or recurred even after prior treatments. The main goal is to see how many participants respond to zanzalintinib, meaning their tumor shrinks or stops growing, which will be measured over about 12 months. The study aims to enroll 100 participants. The current status of this study is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 100 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, Objective Response Rate, is measured up to approximately 12 months.
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NCT07428616
A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
Recruiting
PHASE2Ages 18+InterventionalTreatmentExelixis
~100 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Zanzalintinib
At a glance
Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR) per Response Assessment in Neuro-oncology (RANO) as Assessed by Blinded Independent Central Review (BICR)
Measured over Up to approximately 12 months
Conditions
Where it's being run
12 sites across 9 statesFlorida2
New York2
Texas2
Alabama1
Arizona1
Missouri1
North Carolina1
Virginia1
Study leadership
- Study Director · STUDY_DIRECTOR · Exelixis
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Exclusion
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.
What this trial measures
- Objective Response Rate (ORR) per Response Assessment in Neuro-oncology (RANO) as Assessed by Blinded Independent Central Review (BICR)Up to approximately 12 months