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A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma

RecruitingPhase 2

A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: Exelixis · Participants: 100 · Started: May 21, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07428616

Locations in the U.S.

AlabamaUniversity of Alabama, Birmingham
ArizonaMayo Clinic_Arizona, Phoenix
CaliforniaProvidence - Saint John's Health Center, Santa Monica
FloridaMayo Clinic_Jacksonville, Jacksonville
Baptist Health Miami Cancer Institute, Miami
LouisianaLSU Health Science Center, New Orleans
MassachusettsMassachusetts General Hospital, Boston
MissouriWashington University School of Medicine, St Louis
New YorkMemorial Sloan-Kettering Cancer Center, New York
Mayo Clinic_Rochester, Rochester
North CarolinaDuke University, Durham
OhioThe Ohio State University College of Medicine (OSUCOM), Columbus
Rhode IslandBrown University Health Cancer Institute, Providence
TexasUT MD Anderson Cancer Center, Houston
UT Health San Antonio Mays Cancer Center, San Antonio
VirginiaInova Center for Personalized Health, Fairfax
WisconsinUW Carbone Cancer Center, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.