RecruitingPhase 2NCT07708961

Temozolomide, With or Without WSD0922-FU, for the Treatment of EGFR-Mutant, IDH-Wildtype Glioblastoma

Randomized Phase II Trial to Evaluate the Efficacy of WSD0922-FU When Combined With Adjuvant Temozolomide in Patients With EGFR Mutant Glioblastoma


Sponsor

Mayo Clinic

Enrollment

60 participants

Start Date

Aug 28, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial compares the effect of adding WSD0922-FU to temozolomide versus temozolomide alone in slowing disease progression in patients with Epidermal Growth Factor Receptor (EGFR)-mutant, IDH-wildtype glioblastoma. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. WSD0922-FU is a targeted treatment which blocks EGFR. It is able to get into the brain and spinal cord and help treat those types of tumors. Adding WSD0922-FU to the usual treatment with temozolomide may be more effective in slowing disease progression, compared to temozolomide alone, in patients with EGFR-mutant, IDH-wildtype glioblastoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Archive Sample Retrieval, a procedure called Biospecimen Collection, and others for people with glioblastoma, idh-wildtype. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREArchive Sample Retrieval

Archived tumor specimens will be retrieved if available from original surgery for glioblastoma.

PROCEDUREBiospecimen Collection

Undergo collection of blood, cerebrospinal fluid (CSF), and/or tumor tissue samples

PROCEDUREChest Radiography

Undergo chest x-ray

PROCEDUREEchocardiography Test

Undergo ECHO

DRUGEGFR/EGFRvIII Inhibitor WSD0922-FU

Given PO

PROCEDUREMagnetic Resonance Imaging

Undergo brain MRI

DRUGTemozolomide

Given PO


Locations(3)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT07708961


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