A Phase 2 Study Of Zanzalintinib For Patients With Recurrent Or Metastatic Olfactory Neuroblastoma

Starting soon · Phase 2

Conditions studied: Metastatic Olfactory Neuroblastoma

In brief

The goal of this clinical research study is to learn if zanzalintinib can help to control recurrent/metastatic ONB. The safety of zanzalintinib will also be studied.

Key facts

Study ID

NCT07527169

Run by

M.D. Anderson Cancer Center

People needed

16

Starts

2026-10-01

Expected to finish

2030-07-01

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects must meet all the following inclusion criteria to be eligible for participation in this study:
• Subjects ≥18 years with histology-proven R/M ONB.
• Not amenable to curative intent surgery or radiotherapy
• Measurable disease per RECIST 1.1
• Performance status ECOG of 0 or 1
• VEGFR-inhibitor naïve (R/M ONB never treated with VEGFR inhibitors including Zanzalintinib)
• Adequate organ and marrow function, based upon meeting all the following laboratory criteria within 14 days before first dose of study treatment
• Hemoglobin ≥ 9 g/dL without transfusion within 2 weeks prior to screening laboratory sample collection.
• Absolute neutrophil count ≥ 1500/mm3 (≥ 1.5 GI/L) without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection.
• Platelets ≥ 100 x 109/mL without transfusion within 2 weeks of screening laboratory sample collection.
• Laboratory measurements, renal function:
• Creatinine clearance ≥ 40 mL/min as assessed by the Cockcroft-Gault equation
• Urine protein creatinine ration (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol creatinine)
• Laboratory measurements, hepatic function:
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x ULN. For subjects with documented bone metastasis ALP ≤ 5 x ULN.
• For subjects with CRPC and bone metastasis ALP ≤ 10 x ULN if predominantly bone-specific ALP.
• Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3 x ULN ).
• International Normalized Ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN ).
• Sexually active fertile subjects and their partners must agree to use highly effective method of contraception (defined in Appendix A) during the course of the study and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (eg, condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.
• a. Through 186 days after the last dose of zanzalintinib for women of childbearing potential (WOCBP) or through 96 days after the last dose of zanzalintinib for men
• Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman > 45 years-of-age in the absence of other biological or physiological causes. In addition, females < 55 years-of-age must have a serum follicle stimulating hormone [FSH] level > 40 mIU/mL to confirm menopause). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.
• Capable of understanding and complying with protocol requirement and must have signed informed consent.

You may not qualify if…

• All Patients
• Patients who meet any of the following exclusion criteria are not eligible to be enrolled in this study:
• Prior radiation therapy for bone metastasis within 2 weeks and any other radiation therapy within 4 weeks, or systemic treatment with radionuclide within 6 weeks before first dose of study treatment; ongoing relevant complications from prior radiation therapy are not eligible.
• Active CNS disease (subjects with asymptomatic and stable, treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks are not considered active)
• Red blood cell transfusion dependence, defined as requiring more than 2 units of packed red blood cell transfusions during the 4-week period prior to screening. Red blood cell transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criterion.
• Receipt of any type of small molecule kinase inhibitor (including Zanzalintinib) within 2 weeks before first dose of study treatment.
• Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.
• Current participation in another interventional clinical study
• Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin inhibitors) and platelet inhibitors (eg, clopidogrel).
• Allowed anticoagulants are the following:
• Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
• Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.
• Note: Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.
• History of previous malignancy other than malignancy treated with curative intent within less than 5 years. Subjects with the following diagnoses represents an exception and may enroll if ≥ 1 year with no evidence of active disease before the first dose of the study drug.:
• Non-melanoma skin cancers with no current evidence of disease
• Melanoma in situ with no current evidence of disease
• Localized cancer of the prostate with prostate-specific antigen of <1 ng/mL
• Treated or localized well-differentiated thyroid cancer
• Treated cervical carcinoma in situ
• Treated ductal/lobular carcinoma in situ of the breast
• The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
• Unstable of deteriorating cardiovascular disorders:
• Congestive heart failure New York Heart Association Class 3 or 4, class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, Torsades de pointes).
• Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment.
• Stroke (including transient ischemic attack [TIA]), myocardial infarction, or other clinically significant arterial thrombotic and/or ischemic event within 6 months before first dose of study treatment.

Where it is running

• UT MD Anderson — Houston, Texas, United States

Full record on ClinicalTrials.gov

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