Clinical trial for Glioblastoma, IDH-Wildtype
Official title Temozolomide, With or Without WSD0922-FU, for the Treatment of EGFR-Mutant, IDH-Wildtype Glioblastoma
ClinicalTrials.gov ID: NCT07708961
What this study is testing
What is WSD0922-FU?
an investigational oral medicine being studied for EGFR‑mutant, IDH‑wildtype glioblastoma is designed to block the EGFR/EGFRvIII receptor signaling that helps tumor cells grow
Also referred to as BBB Penetrable EGFR/EGFRvIII Inhibitor WSD0922-FU, EGFR Mutant Inhibitor WSD0922-FU, WSD 0922-FU, WSD-0922-FU.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is looking to see if adding WSD0922-FU to temozolomide slows tumor growth more than temozolomide alone.
- Who it's for
- Adults who have EGFR‑mutant, IDH‑wildtype glioblastoma.
- What's involved
- You will take temozolomide, and some participants will also receive the targeted drug WSD0922-FU. You will have regular clinic visits and scans to check the tumor.
- Time commitment
- The trial runs for several months and includes periodic treatment cycles and follow‑up visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>= 18 years
- Histopathologic diagnosis of glioblastoma, IDH-wildtype [as defined by the 2021 World Health Organization (WHO) classification of central nervous...
- 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...
- EGFR mutation includes both deoxyribonucleic acid (DNA) sequence variants (e.g. point mutations, etc.) and transcript variants (e.g. EGFRvIII, etc.)
You likely can't join if
- Patients deemed to have progressive disease based on clinical deterioration after chemoradiation or radiographic progression outside of the radiation...
- EXCEPTION: Patients deemed to have pseudoprogression are eligible; however, this should be controlled on =\< 4 mg of dexamethasone and should not...
- Pregnant persons
- Nursing persons
- Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
- Surgery for glioblastoma =\< 3 weeks prior to registration
See the full eligibility 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.) 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...
- 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
- 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
- Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
- Surgery for glioblastoma =\< 3 weeks prior to registration
- Radiation therapy =\< 2 weeks prior to registration
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.