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

NCT07527169 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2025-0798
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Olfactory Neuroblastoma

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Phase 2: Treatment with Zanzalintinib

EXPERIMENTAL

Participants will be enrolled into a single cohort (N=16). Enrolled participants will receive Zanzalintinib at a dose of 60 mg orally once daily in a 28-day cycle.

Drug: Zanzalintinib

Interventions

Zanzalintinib DRUG

Given orally

Also known as: XL092

Phase 2: Treatment with Zanzalintinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• All Patients
• 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)
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Website

MeSH Terms

Conditions

Esthesioneuroblastoma, Olfactory

Condition Hierarchy (Ancestors)

Neuroblastoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Olfactory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Luana Sousa, MD

  UT MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luana Sousa, MD

CONTACT

713-628-5674; lgsousa@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)