Zanzalintinib: Administered as specified in the treatment arm.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy 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.
Primary outcome measure(s)
Objective Response Rate (ORR) per Response Assessment in Neuro-oncology (RANO) as Assessed by Blinded Independent Central Review (BICR) — Up to approximately 12 months
Trial sites (17)
Facility
City
Region
Status
University of Alabama
Birmingham
Alabama
Recruiting
Mayo Clinic_Arizona
Phoenix
Arizona
Recruiting
Providence - Saint John's Health Center
Santa Monica
California
Recruiting
Mayo Clinic_Jacksonville
Jacksonville
Florida
Recruiting
Baptist Health Miami Cancer Institute
Miami
Florida
Recruiting
LSU Health Science Center
New Orleans
Louisiana
Recruiting
Massachusetts General Hospital
Boston
Massachusetts
Recruiting
Washington University School of Medicine
St Louis
Missouri
Recruiting
Memorial Sloan-Kettering Cancer Center
New York
New York
Recruiting
Mayo Clinic_Rochester
Rochester
New York
Recruiting
Duke University
Durham
North Carolina
Recruiting
The Ohio State University College of Medicine (OSUCOM)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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