Trials / Recruiting

RecruitingNCT06959641

XL092 for the Treatment of Locally Advanced or Metastatic Radioiodine Refractory Differentiated Thyroid Cancer

A Phase 2 Open Label Study of XL092 as First Line Therapy in Radioiodine Refractory Differentiated Thyroid Cancer

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 33 (estimated)

Sponsor: Northwestern University · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase II trial tests how well XL092 works for the treatment of patients with differentiated thyroid cancer that has not responded to previous treatment with radioiodine (radioiodine refractory) and that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). XL092 is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing.

Detailed description

PRIMARY OBJECTIVE: I. Assess efficacy of the treatment zanzalintinib (XL092) in radioiodine refractory/radioactive iodine refractory (RAIR) differentiated thyroid cancer (DTC) patients by evaluating the proportion of patients alive and without progression at 12 months. SECONDARY OBJECTIVES: I. Assess efficacy of XL092 treatment in RAIR DTC patients by imaging. II. Assess efficacy of the treatment XL092 in RAIR DTC patients by evaluating progression free survival. III. Assess efficacy for RAIR DTC patients treated with XL092 evaluating the overall survival time. IV. Assess the safety and tolerability of XL092 monotherapy in patients with RAIR DTC. V. Characterize the quality of life in RAIR DTC patients treated with XL092 monotherapy. EXPLORATORY OBJECTIVES: I. Assess immune cell landscape in XL092 treated patients. II. Assess by next generation sequencing (NGS) and biomarker analysis, mechanisms that lead to response or failure to XL092. OUTLINE: Patients receive XL092 orally (PO) daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) and x-ray imaging, and blood and urine sample collection throughout the study. After completion of study treatment, patients are followed up at 30 days then every 3 months for 12 months.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood and urine sample collection
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Survey Administration	Ancillary studies
PROCEDURE	X-Ray Imaging	Undergo x-ray imaging
DRUG	Zanzalintinib	Given PO

Timeline

Start date: 2025-06-06
Primary completion: 2028-09-11
Completion: 2030-09-11
First posted: 2025-05-06
Last updated: 2025-06-11

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06959641. Inclusion in this directory is not an endorsement.