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Temozolomide with WSD0922-FU for Glioblastoma

This study is testing if adding a drug called WSD0922-FU to standard temozolomide treatment can better slow down the growth of a specific type of brain tumor called glioblastoma. This particular glioblastoma must have an "EGFR mutation" and be "IDH-wildtype" (these are specific genetic features of the tumor). Temozolomide works by damaging cancer cell DNA, while WSD0922-FU is a targeted treatment that blocks EGFR and can reach brain tumors. Researchers want to see if combining these two treatments is more effective than temozolomide alone. You may be able to join if you are 18 or older and have this specific type of glioblastoma with an EGFR mutation. The study plans to enroll 60 participants, but its current status is unclear.

Study design
This is a Phase II interventional study comparing two treatment approaches for glioblastoma. It aims to enroll 60 participants.
What's involved
You would undergo collection of blood, cerebrospinal fluid (CSF), and/or tumor tissue samples, as well as chest x-rays and echocardiograms (ECHO). Archived tumor samples may also be retrieved.
Compensation
Not stated in the trial record.
Follow-up
The study will track how long participants live without their disease getting worse for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07708961

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~60 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:Archive Sample RetrievalBiospecimen CollectionChest RadiographyEchocardiography TestEGFR/EGFRvIII Inhibitor WSD0922-FUMagnetic Resonance Imaging

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over Up to 5 years

Conditions

Glioblastoma, IDH-Wildtype

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NCT07708961

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Arizona

    Scottsdale, Arizonastudy coordinator listed

    Not yet recruiting

  • Mayo Clinic in Florida

    Jacksonville, Floridastudy coordinator listed

    Not yet recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sani H. Kizilbash, MD, MPH · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

Exclusion

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
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. Examples include (but are not limited to) refractory nausea and vomiting (if not controlled by supportive therapy), inability to swallow the formulated product, previous significant bowel resection, other chronic gastrointestinal diseases, etc
Uncontrolled intercurrent illness including, but not limited to:
Ongoing or active infection
Severe skin lesions such as skin/pressure ulcers, chronic leg ulcers or non-healing wounds.
Active history of keratitis
Symptomatic CNS complications that require urgent neurosurgical or medical (e.g. mannitol) intervention
Known intracranial hemorrhage which is unrelated to tumor
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
Or psychiatric illness/social situations that would limit compliance with study requirements
Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Other active malignancy within the last 3 years that would interfere with treatment on this protocol
EXCEPTIONS: non-melanoma skin cancer, carcinoma in situ of the cervix, patients on hormonal therapy for treated breast or prostate cancer
History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

What this trial measures

  • Progression-free survival (PFS)Up to 5 years

    Defined as the time from randomization to the time of documented disease progression or death. PFS will be evaluated for each arm, where patients will be evaluated based on the treatment arm to which they were randomized and will include only those who are eligible and have received any protocol therapy to be considered evaluable. PFS distributions will be graphically and quantitatively compared using Kaplan-Meier methods. These methods will be used to estimate the median PFS as well as 1-year estimates for PFS by treatment arm along with corresponding 95% confidence intervals. Cox proportional hazards models will also be used to assess influential factors on PFS both in the univariate and the multivariable settings.