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New hope for brain tumor patients: drug trial targets recurrent meningioma

NCT ID NCT07428616

Disease control Sponsor: Exelixis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 6 times

Summary

This phase 2 trial tests a drug called zanzalintinib in 100 people with meningioma that has returned or worsened after standard treatments like surgery or radiation. The goal is to see if the drug can shrink tumors or slow the disease. Participants take the drug by mouth, and researchers will monitor tumor response and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zanzalintinib (a drug taken by mouth that targets tumor growth)
What this could lead to
If it works, this could offer a new treatment option for people with meningioma that has come back or worsened after standard therapies.
What could go wrong
This is a mid-stage trial with only 100 participants, so results may not apply to everyone. The drug may not shrink tumors or improve survival, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

brain cancer meningioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Meningioma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    17 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Baptist Health Miami Cancer Institute

    RECRUITING

    Miami, Florida, 33176, United States

  • Brown University Health Cancer Institute

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Inova Center for Personalized Health

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • LSU Health Science Center

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic_Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic_Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic_Rochester

    RECRUITING

    Rochester, New York, 55905, United States

  • Memorial Sloan-Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Providence - Saint John's Health Center

    RECRUITING

    Santa Monica, California, 90404, United States

  • The Ohio State University College of Medicine (OSUCOM)

    RECRUITING

    Columbus, Ohio, 43210, United States

  • UT Health San Antonio Mays Cancer Center

    RECRUITING

    San Antonio, Texas, 78229, United States

  • UT MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UW Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • University of Alabama

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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