A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma (NCT07428616) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
100 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 syste…
What they're measuring
1
Objective Response Rate (ORR) per Response Assessment in Neuro-oncology (RANO) as Assessed by Blinded Independent Central Review (BICR)