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

Starting soon · Phase 2

Conditions studied: Glioblastoma, IDH-Wildtype

In brief

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 facts

Study ID

NCT07708961

Run by

Mayo Clinic

People needed

60

Starts

2026-08-16

Expected to finish

2036-07-31

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.) and transcript variants (e.g. EGFRvIII, etc.)
• EXCEPTIONS: Glioblastomas which are EGFR wildtype with amplification are excluded. Glioblastomas which only have EGFR variants of unknown significance (without any pathogenic EGFR mutations) are also excluded
• Patients must have completed standard radiation (60 Gy in 30 fractions) with concurrent temozolomide (missing no more than 2 weeks of temozolomide), and adequately recovered from treatment related toxicities
• NOTE: Adjuvant temozolomide must not have been initiated
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Hemoglobin > 9.0 g/dL (obtained =< 14 days prior to registration)
• Leukocytes > 3.0 x 10\^9/L (obtained =< 14 days prior to registration)
• Absolute neutrophil count (ANC) > 1.5 x 10\^9/L (obtained =< 14 days prior to registration)
• Platelet count > 100 x 10\^9/L (obtained =< 14 days prior to registration)
• Total bilirubin =< 1.5 x upper limit of normal (ULN) (< 3 x ULN for patients with Gilbert's disease) (obtained =< 14 days prior to registration)
• Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 3 x ULN (obtained =< 14 days prior to registration)
• Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained =< 14 days prior to registration)
• Calculated creatinine clearance >= 45 mL/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration)
• Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
• Provide written informed consent
• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
• Must be willing to take light-protective measures during the study and for two weeks after last dose of WSD0922-FU
• Willingness to provide mandatory tissue specimens for correlative research

You may not qualify if…

• 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
• Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
• Any of the following prior therapies:
• Surgery for glioblastoma =< 3 weeks prior to registration
• Radiation therapy =< 2 weeks prior to registration
• Systemic therapies intended for the management of the glioblastoma, including but not limited to:
• Targeted therapies
• EGFR inhibitors
• Alkylating chemotherapy
• Adjuvant temozolomide (note that temozolomide administered concurrent with radiation is NOT an exclusion criterion)
• Immunotherapy
• Biologics
• Any other systemic therapies [Food and Drug Administration (FDA) approved, off-label, investigational]
• Bevacizumab
• Non-enzyme-inducing anticonvulsants < 2 weeks prior to registration
• Strong inducers and strong inhibitors of CYP3A < 14 days prior to registration
• Failure to adequately recover from any adverse events or complications related to any of the following therapies received prior to registration:
• Craniotomy and resection of tumor
• Stereotactic biopsy of tumor
• Other major surgical procedure
• Radiation therapy < 2 weeks prior to registration

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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