MeningiomaPhase 2STELLAR-201NCT07428616
A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
A Phase 2 study testing Zanzalintinib in people with Meningioma, run by Exelixis at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma
- What is being tested?
- Zanzalintinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 20 sitesUnited States
- Study dates
- 21 May 2026to 30 Sep 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Backup or International contact
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
University of Alabama
Birmingham, Alabama, 35294
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Northwestern University
Chicago, Illinois, 60611
- Recruiting
The Ohio State University College of Medicine (OSUCOM)
Columbus, Ohio, 43210
- Recruiting
Duke University
Durham, North Carolina, 27710
- Recruiting
Inova Center for Personalized Health
Fairfax, Virginia, 22031
- Recruiting
UT MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Mayo Clinic_Jacksonville
Jacksonville, Florida, 32224
- Recruiting
UW Carbone Cancer Center
Madison, Wisconsin, 53792
- Recruiting
Baptist Health Miami Cancer Institute
Miami, Florida, 33176
- Recruiting
LSU Health Science Center
New Orleans, Louisiana, 70112
- Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
- Recruiting
Mayo Clinic_Arizona
Phoenix, Arizona, 85054
- Recruiting
Brown University Health Cancer Institute
Providence, Rhode Island, 02903
- Recruiting
Mayo Clinic_Rochester
Rochester, New York, 55905
- Recruiting
UT Health San Antonio Mays Cancer Center
San Antonio, Texas, 78229
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
- Recruiting
Providence - Saint John's Health Center
Santa Monica, California, 90404
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
- Recruiting
Tampa General Hospital
Tampa, Florida, 33619
About this study
Official title: A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
The objective of the study is to evaluate efficacy and safety of zanzalintinib in participants with recurrent or progressive meningioma refractory to standard therapies.
- Conditions
- Meningioma
- Being tested
- Zanzalintinib
- Keywords
- Meningioma, Recurrent Meningioma, Progressive Meningioma, Atypical Meningioma, Anaplastic Meningioma, Brain, Zanzalintinib, XL092, Grade 1 Meningioma, Grade 2 Meningioma, Grade 3 Meningioma, Intracranial Neoplasms, Extracranial Meningioma
- Medical subject headings
- Meningioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanzalintinibDrug
Also called XL092
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Zanzalintinib | Experimental | Participants will receive zanzalintinib once daily (QD). Receives: Drug: Zanzalintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) per Response Assessment in Neuro-oncology (RANO) as Assessed by Blinded Independent Central Review (BICR)
Measured: Up to approximately 12 months
Secondary outcomes (7)
Progression-free Survival at 6 Months (PFS-6) per RANO as Assessed by BICR and Investigator
Measured: Up to 6 months
Duration of Response (DOR) per RANO as Assessed by BICR and Investigator
Measured: Up to approximately 48 months
Progression-free Survival (PFS) per RANO as Assessed by BICR and Investigator
Measured: Up to approximately 48 months
Overall Survival (OS)
Measured: Up to approximately 48 months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to approximately 48 months
Change from Baseline in Neurologic Function as Measured by the Neurologic Assessment in Neuro-oncology (NANO) Scale Score
Measured: Baseline up to approximately 13 months
Change from Baseline in Health-related Quality of Life (HRQoL) as Measured by the EuroQol 5-dimension 5-level Questionnaire (EQ-5D-5L) Score
Measured: Baseline up to approximately 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start21 May 2026
- Primary completion29 Feb 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by ExelixisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exelixis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Exelixis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428616
- Sponsor's protocol ID
- XL092-201
- Acronym
- STELLAR-201
- Status last verified
- Oct 2026
- First submitted
- 19 Feb 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No