Actively Recruiting
ATM-Inhibitor WSD0628 in Combination With Radiation Therapy for Treatment of Recurrent High-Grade Glioma
Led by Mayo Clinic · Updated on 2026-04-21
94
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to test WSD0628 in combination with radiation therapy for recurrent brain tumors.
CONDITIONS
Official Title
ATM-Inhibitor WSD0628 in Combination With Radiation Therapy for Treatment of Recurrent High-Grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological confirmation of glioblastoma, IDH-wildtype, or grade 3 or 4 IDH1/2 mutant astrocytoma
- Measurable disease as defined in study Section 11.0
- Disease progression after prior radiation and chemotherapy for glioma
- Minimum life expectancy of at least 3 months
- For Dose Expansion group: plan for radiosurgery and surgical resection as part of routine care
- ECOG Performance Status of 0, 1, or 2
- Laboratory values within 15 days prior to registration: hemoglobin ≥9.0 g/dL, leukocytes ≥3.0 x 10^9/L, ANC ≥1500/mm3 or 1.5 x 10^9/L, platelets ≥100,000/mm3 or 100 x 10^9/L, total bilirubin ≤1.5 x upper limit normal (ULN) or <3 mg/dL if Gilbert's disease, ALT and AST ≤3 x ULN, PT/INR/aPTT ≤1.5 x ULN or in target range if on anticoagulants
- Calculated creatinine clearance ≥45 ml/min using Cockcroft-Gault formula
- Negative pregnancy test within 7 days prior to registration for persons of childbearing potential
- Willing to take light-protective measures during study and for two weeks after last dose
- Provide written informed consent
- Willing to return for follow-up during Active Monitoring Phase
- Willing to provide mandatory tissue samples for research
You will not qualify if you...
- Pregnant or nursing persons
- Persons of childbearing potential or able to father a child unwilling to use adequate contraception
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting compliance
- Marked baseline QT/QTc prolongation (QTc >480 ms), history of risk factors for Torsades de Pointes, use of QT-prolonging medications, recent myocardial infarction (within 6 months), or life-threatening ventricular arrhythmias
- Known bleeding disorders or history of significant hemorrhage including intracranial tumor-related bleeding
- Use of enzyme-inducing anticonvulsants within two weeks prior to enrollment (patients may enroll after switching to non-enzyme-inducing anticonvulsants)
- Use of more than 8 mg dexamethasone daily or equivalent steroid dose at enrollment
- Radiation therapy within 26 weeks prior to registration
- Chemotherapy, immunotherapy, investigational drugs within 4 weeks prior to registration, or carmustine/lomustine within 6 weeks prior
- History of interstitial lung disease, radiation pneumonitis requiring steroids, or active interstitial lung disease
- Hypersensitivity to WSD0628 or similar compounds
- Severe nausea/vomiting not controlled by therapy, chronic GI diseases, inability to swallow study drug, or prior major bowel surgery affecting absorption
- Uncontrolled high blood pressure
- History of severe brain injury or stroke
- Receiving other investigational agents for the primary tumor
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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