Recruiting
Phase 2

Zanzalintinib

Sponsor:

Exelixis

Code:

NCT07428616

Conditions

Meningioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zanzalintinib

Study Details

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

Study ID

NCT07428616

Start date

May 21, 2026

Status verified date

Jul, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Feb 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zanzalintinib

Participants will receive zanzalintinib once daily (QD).

Interventions

Zanzalintinib

Administered as specified in the treatment arm.

Primary outcome measure

  • Objective Response Rate (ORR) per Response Assessment in Neuro-oncology (RANO) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 12 months ]

Central Contacts and Locations

Central contacts

Exelixis Clinical Trials

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

Backup or International

650-837-7400

Locations

University of Alabama

Recruiting

Birmingham, Alabama, United States, 35294

Mayo Clinic_Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Mayo Clinic_Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Baptist Health Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Mayo Clinic_Rochester

Recruiting

Rochester, New York, United States, 55905

Duke University

Recruiting

Durham, North Carolina, United States, 27710

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

UT Health San Antonio Mays Cancer Center

Recruiting

San Antonio, Texas, United States, 78229

Inova Center for Personalized Health

Recruiting

Fairfax, Virginia, United States, 22031

UW Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

Exelixis

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Exelixis on 2026-07-27.