NCT07527169

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives: • To assess the efficacy of Zanzalintinib in patients with R/M ONB Endpoint ORR, defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) as measured by response evaluation criteria in solid tumors (RECIST), version 1.1, as determined by investigator radiologist assessment. Secondary Objectives: • To assess the metabolic response of Zanzalintinib in patients with R/M ONB Endpoint Objective Metabolic Response Rate (OMRR), defined as the proportion of patients who achieve a complete metabolic response (CMR) or partial metabolic response (PMR), as measured by PERCIST v.1.0 using DOTATATE-PET imaging, based on investigator assessment by radiology and/or nuclear medicine. • To estimate the median duration of response (DOR) Endpoint DOR, defined as time from first documentation of CR or PR to the earliest date of documented disease progression or death from any cause, or last follow-up without disease progression or death, whichever occurs first. • Duration of metabolic response (DOMR) Endpoint DOMR, defined as time from first documentation of CMR or PMR to the earliest date of documented metabolic disease progression or death from any cause, or last follow-up without disease progression or death, whichever occurs first. • Time to response Endpoint Among objective responders (CR and PR), the time between the date treatment was started (C1D1) and first radiological evidence of CR or PR. • To estimate the median progression-free survival (PFS) and 12-months PFS rate Endpoint PFS, defined as the time from the date of dose initiation to the earliest date of documented disease progression, or death from any cause, or last follow-up without disease progression or death, whichever occurs first. To estimate the median overall survival (OS) and 12-months OS Endpoint OS, defined as time from date of dose initiation to death from any cause or last follow-up without death. • To assess safety of Zanzalintinib Endpoint Safety will be measured as the incidence of adverse events (AEs) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. Tertiary/Exploratory Objectives • To explore biomarkers that may predict response to therapy Endpoint Correlation of clinical response with biomarkers at baseline and/or on treatment. Correlatives analysis may include, but are not limited to, genomic (tumor molecular profiling, RNAseq) and proteomics (mIF or IMC) profiling.

Conditions

• Metastatic Olfactory Neuroblastoma

Interventions

Type	Name	Description
DRUG	Zanzalintinib	Given orally

Timeline

• Start date: 2026-10-01
• Primary completion: 2028-07-01
• Completion: 2030-07-01
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study