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Clinical Trials in the USA / NCT07428616
Recruiting Phase 2

A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma

NCT07428616 · tracked via the Priya Life Science USA tracker
Sponsor
Exelixis
Phase
Phase 2
Started
2026-05-21
Last updated
2026-09-08

Condition(s) studied

Meningioma

Investigational drug(s) / intervention(s)

Zanzalintinib

Zanzalintinib: Administered as specified in the treatment arm.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
University of Alabama Birmingham Alabama Recruiting
Mayo Clinic_Arizona Phoenix Arizona Recruiting
Providence - Saint John's Health Center Santa Monica California Recruiting
Mayo Clinic_Jacksonville Jacksonville Florida Recruiting
Baptist Health Miami Cancer Institute Miami Florida Recruiting
LSU Health Science Center New Orleans Louisiana Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Memorial Sloan-Kettering Cancer Center New York New York Recruiting
Mayo Clinic_Rochester Rochester New York Recruiting
Duke University Durham North Carolina Recruiting
The Ohio State University College of Medicine (OSUCOM) Columbus Ohio Recruiting
Brown University Health Cancer Institute Providence Rhode Island Recruiting
UT MD Anderson Cancer Center Houston Texas Recruiting
UT Health San Antonio Mays Cancer Center San Antonio Texas Recruiting
Inova Center for Personalized Health Fairfax Virginia Recruiting
UW Carbone Cancer Center Madison Wisconsin Recruiting

More Exelixis trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07428616 on ClinicalTrials.gov ↗ ← All trials in the USA