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

Conditions

• Glioblastoma, IDH-Wildtype

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Archive Sample Retrieval — PROCEDURE
  Archived tumor specimens will be retrieved if available from original surgery for glioblastoma.
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood, cerebrospinal fluid (CSF), and/or tumor tissue samples
• Chest Radiography — PROCEDURE
  Undergo chest x-ray
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• EGFR/EGFRvIII Inhibitor WSD0922-FU — DRUG
  Given PO
• Magnetic Resonance Imaging — PROCEDURE
  Undergo brain MRI
• Temozolomide — DRUG
  Given PO

Study Details

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.

Key Dates

First listed

Jul 16, 2026

Start date

Aug 16, 2026

Status verified

Jul 2026

Primary completion

Jul 31, 2036

Completion

Jul 31, 2036

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (temozolomide, WSD0922-FU)
  Patients receive temozolomide PO QD on days 1-5 of cycles 1-6 and WSD0922-FU PO BID on days 1-5, 8-12, 15-19, and 22-26 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease recurrence while on therapy and are planning to undergo tumor resection or stereotactic biopsy prior to starting alternative treatment continue receiving WSD0922-FU PO BID on days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle until the time of surgery. Patients also undergo ECHO and MRI throughout the trial and undergo chest x-ray and collection of tissue samples on study. Patients may undergo optional collection of blood and/or cerebrospinal fluid (CSF) samples throughout the trial.
• Active Comparator: Arm B (temozolomide)
  Patients receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience disease recurrence while on therapy and are planning to undergo tumor resection or stereotactic biopsy prior to starting alternative treatment may initiate WSD0922-FU PO BID on days 1-5, 8-12, 15-19, and 22-26 of each cycle. Cycles repeat every 28 days until the time of surgery. Patients also undergo ECHO and MRI throughout the trial and undergo chest x-ray and collection of tissue samples on study. Patients may undergo optional collection of blood and/or CSF samples throughout the trial.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to 5 years ]

Central Contacts

• Clinical Trials Referral Office
  855-776-0015
  [email protected]
• Cancer Center Clinical Trials
  507-293-6386

Locations (3)

Find similar trials in Scottsdale, AZ

Related Studies

• Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
  PHASE1/PHASE2 · Recruiting · Neonc Technologies, Inc. · Beverly Hills, California
• Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial
  PHASE2 · Recruiting · ECOG-ACRIN Cancer Research Group · Los Angeles, California
• Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma
  Recruiting · Mayo Clinic · Phoenix, Arizona
• GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma
  PHASE2 · Recruiting · Mayo Clinic · Rochester, Minnesota