Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 2

A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma

NCT ID: NCT07428616Sponsor: ExelixisLast updated: 2026-05-27

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.

Arms & interventions

  • DrugZanzalintinib

    Administered as specified in the treatment arm.

Outcome measures

Primary

  • 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

Secondary

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

    Time frame: Up to 6 months

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

    Time frame: Up to approximately 48 months

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

    Time frame: Up to approximately 48 months

  • Overall Survival (OS)

    Time frame: Up to approximately 48 months

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

    Time frame: Up to approximately 48 months

  • Change from Baseline in Neurologic Function as Measured by the Neurologic Assessment in Neuro-oncology (NANO) Scale Score

    Time frame: 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

    Time frame: Baseline up to approximately 13 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (3)

Exelixis Site #3

Miami, Florida, 33176

Recruiting

Exelixis Site #2

Houston, Texas, 77030

Recruiting

Exelixis Site #1

San Antonio, Texas, 78229

Recruiting
A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma | Cancerify