A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma

NCT07428616 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: XL092-201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Meningioma

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) per Response Assessment in Neuro-oncology (RANO) as Assessed by Blinded Independent Central Review (BICR)

  Up to approximately 12 months

Secondary Outcomes (7)

• Progression-free Survival at 6 Months (PFS-6) per RANO as Assessed by BICR and Investigator

  Up to 6 months

• Duration of Response (DOR) per RANO as Assessed by BICR and Investigator

  Up to approximately 48 months

• Progression-free Survival (PFS) per RANO as Assessed by BICR and Investigator

  Up to approximately 48 months

• Overall Survival (OS)

  Up to approximately 48 months

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Up to approximately 48 months

Study Arms (1)

Zanzalintinib

EXPERIMENTAL

Participants will receive zanzalintinib once daily (QD).

Drug: Zanzalintinib

Interventions

Zanzalintinib DRUG

Administered as specified in the treatment arm.

Also known as: XL092

Zanzalintinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Exelixis: lead

Study Sites (12)

University of Alabama

Birmingham, Alabama, 35294, United States

RECRUITING

Mayo Clinic_Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

Mayo Clinic_Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

Baptist Health Miami Cancer Institute

Miami, Florida, 33176, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Mayo Clinic_Rochester

Rochester, New York, 55905, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

UT Health San Antonio Mays Cancer Center

San Antonio, Texas, 78229, United States

RECRUITING

Inova Center for Personalized Health

Fairfax, Virginia, 22031, United States

RECRUITING

UW Carbone Cancer Center

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Meningioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Study Officials

• Study Director

  Exelixis

  STUDY DIRECTOR

Central Study Contacts

Exelixis Clinical Trials

CONTACT

1-888-EXELIXIS (888-393-5494); druginfo@exelixis.com

Backup or International

CONTACT

650-837-7400

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 24, 2026
• Study Start: May 21, 2026
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)