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