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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

Qualifiers

Age >= 18 years

Histopathologic diagnosis of glioblastoma, IDH-wildtype [as defined by the 2021 World Health Organization (WHO) classification of central nervous system (CNS) tumors] on primary pathology review

NOTE: MGMT promoter methylation status must have been performed

Glioblastomas must have a pathogenic EGFR mutation, with or without EGFR amplification, detected by Clinical Laboratory Improvement Act (CLIA)-certified next-generation sequencing

Disqualifiers

Patients deemed to have progressive disease based on clinical deterioration after chemoradiation or radiographic progression outside of the radiation field

EXCEPTION: Patients deemed to have pseudoprogression are eligible; however, this should be controlled on =< 4 mg of dexamethasone and should not require bevacizumab at study onset

Pregnant persons

Nursing persons

Trial design

Treatments tested in this trial

  • Archive Sample Retrieval
  • Biospecimen Collection
  • Chest Radiography
  • Echocardiography Test
  • EGFR/EGFRvIII Inhibitor WSD0922-FU
  • Magnetic Resonance Imaging
  • Temozolomide

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators