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

NCT07708961 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-22

No results posted yet for this study

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.

Conditions

  • Glioblastoma, IDH-Wildtype

Interventions

PROCEDURE

Archive Sample Retrieval

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

PROCEDURE

Biospecimen Collection

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

PROCEDURE

Chest Radiography

Undergo chest x-ray

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

EGFR/EGFRvIII Inhibitor WSD0922-FU

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo brain MRI

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

Principal Investigators

  • Sani H. Kizilbash, MD, MPH · Mayo Clinic in Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-16
Primary Completion
2036-07-31
Completion
2036-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07708961 on ClinicalTrials.gov