Not Yet RecruitingPhase 2

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

United States16 participantsStarted 2026-10-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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).
✕. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).

What they're measuring

Safety and Adverse Events (AEs)

Timeframe: Through study completion; an average of 1 year

Trial details

NCT IDNCT07527169

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-01

Contact for this trial

Luana Sousa, MD

713-628-5674 lgsousa@mdanderson.org

View on ClinicalTrials.gov More Metastatic Olfactory Neuroblastoma trials