Zanzalintinib for recurrent or progressive meningioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional study evaluating the safety and activity of zanzalintinib in patients with recurrent or progressive meningioma after standard therapy. Eligible participants have histologically confirmed WHO grade 1–3 meningioma and measurable disease with radiographic progression. Participants must have had at least one prior radiotherapy course (unless contraindicated) and a KPS of 60% or higher. The study will monitor tumor response and safety to determine if the drug offers clinical benefit in this setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic_Arizona
  Phoenix, Arizona, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Providence - Saint John's Health Center
  Santa Monica, California, United States Recruiting
• Mayo Clinic_Jacksonville
  Jacksonville, Florida, United States Recruiting
• Baptist Health Miami Cancer Institute
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Exelixis Clinical Trials
• Email: druginfo@exelixis.com
• Phone: 1-888-EXELIXIS (888-393-5494)

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.