A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma

NCT07428616 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: XL092-201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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 (3)

Exelixis Site #3

Miami, Florida, 33176, United States

Location

Exelixis Site #2

Houston, Texas, 77030, United States

Location

Exelixis Site #1

San Antonio, Texas, 78229, United States

Location

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 (Estimated): May 31, 2026
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)