Actively Recruiting
A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
Led by Exelixis · Updated on 2026-05-27
100
Participants Needed
3
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the drug zanzalintinib in adults with recurrent or progressive meningioma that has not responded to standard treatments such as surgery or radiation. This Phase 2, single-arm, open-label study focuses on participants whose tumors continue to grow despite previous therapies, aiming to understand the drug's impact on tumor response and other health outcomes. Participants will receive zanzalintinib once daily. The study will last up to approximately 48 months, with the primary outcome measuring the tumor's response after up to 12 months. Secondary outcomes include progression-free survival, duration of response, overall survival, treatment side effects, neurologic function, and quality of life. The study involves regular assessments according to established neuro-oncology criteria. During the trial, participants will undergo imaging and clinical evaluations to monitor tumor changes and health status. Researchers will track neurological function and quality of life using specific scales and questionnaires. Safety will be closely monitored throughout the study, with follow-up visits occurring for up to four years. This structured observation aims to provide comprehensive data on zanzalintinib's effects in this patient population.
CONDITIONS
Brief Title
A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed World Health Organization (WHO) grade 1, 2, or 3 meningioma.
- Recurrent or progressive disease after standard therapy or ineligible for standard therapy.
- At least one prior course of meningioma-directed radiotherapy if not contraindicated.
- Radiologically documented tumor progression (growth > 15% or new lesions) within 6 months.
- At least 24 weeks since completion of external beam radiation, brachytherapy, or radiosurgery.
- Measurable disease by RANO meningioma criteria within 14 days prior to treatment.
- Karnofsky performance status (KPS) of 60% or higher.
- Adequate organ and marrow function within 14 days of treatment start.
You will not qualify if you...
- Prior history of hypertensive encephalopathy.
- Extracranial lesions invading major blood vessels like inferior vena cava, pulmonary artery, or aorta.
- Contraindication to magnetic resonance imaging (MRI).
- Local therapy indicated by investigator.
- Receipt of cytotoxic, biologic, or systemic anticancer therapy within 4 weeks or 5 half-lives before treatment.
- Recent surgery without completed wound healing (≥ 8 weeks for major, ≥ 7 days for minor).
- Uncontrolled or significant recent illnesses including uncontrolled hypertension, high-risk gastrointestinal disorders, significant bleeding, or other serious disorders.
- Requirement for hemodialysis or peritoneal dialysis.
- History of solid organ or allogeneic stem cell transplant.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 12 months
Participants receive zanzalintinib once daily as the study treatment.
Regular visits during treatment period
Duration - Up to approximately 48 months
Participants are monitored for safety and long-term outcomes after treatment ends.
Periodic visits for up to 48 months
Trial Site Locations
Total: 3 locations
1
Exelixis Site #3
Miami, Florida, United States, 33176
Actively Recruiting
2
Exelixis Site #2
Houston, Texas, United States, 77030
Actively Recruiting
3
Exelixis Site #1
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
E
Exelixis Clinical Trials
B
Backup or International
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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