Mayo Clinic
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.
Inclusion Criteria: * 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 * EGFR mutation includes both deoxyribonucleic acid (DNA) sequence variants (e.g. point mutations, etc.) an…
Archived tumor specimens will be retrieved if available from original surgery for glioblastoma.
Undergo collection of blood, cerebrospinal fluid (CSF), and/or tumor tissue samples
Undergo chest x-ray
Undergo ECHO
Given PO
Undergo brain MRI
Given PO
Arctuva estimate
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