WSD0628 with Radiation for Recurrent High-Grade Glioma
This study is testing a new drug called WSD0628 in combination with radiation therapy for people with recurrent high-grade glioma (a type of aggressive brain tumor). WSD0628 is designed to make radiation therapy more effective. The main goals are to find the highest safe dose of WSD0628 when given with radiation and to see what dose is recommended for future studies. You might be able to join if you are at least 18 years old, have a confirmed diagnosis of glioblastoma (IDH-wildtype) or a Grade 3 or 4 IDH1/2 mutant astrocytoma, and your tumor has grown after previous treatment. The study is currently unclear on its recruitment status.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is a single-arm, open-label, dose-escalation and dose-expansion study, planning to enroll approximately 94 adult patients.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at 4 weeks after the last day of radiation therapy, up to 60 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05917145
ATM-Inhibitor WSD0628 in Combination With Radiation Therapy for Treatment of Recurrent High-Grade Glioma
Recruiting
PHASE1Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~94 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:WSD0628
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the maximum tolerated dose of WSD0628 in combination with radiation therapy for patients with recurrent high-grade glioma.
Measured over 4 weeks after last day of RT (up to 60 days)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Study leadership
- William G. Breen, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
- Jann N. Sarkaria, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age ≥ 18 years
Histological confirmation of one of the following:
Glioblastoma, IDH-wildtype
Grade 3 or 4 IDH1/2 mutant astrocytoma (2021 WHO classification)
Measurable disease as defined in Section 11.0
Disease progression after previous treatment for glioma with radiation and chemotherapy
Minimum life expectancy of at least 3 months
Group C only: Dose Expansion, Brain Tumor Penetration Group: plan for radiosurgery and surgical resection as part of routine clinical care
ECOG Performance Status (PS) 0, 1 or 2 (Appendix I)
The following laboratory values obtained ≤15 days prior to registration:
Hemoglobin ≥9.0 g/dL
Leukocytes ≥3.0 x 109/L
Absolute neutrophil count (ANC) ≥1500/mm3 or 1.5 x 109/L
Platelet count ≥100,000/mm3 or 100 x 109/L
Total bilirubin ≤1.5 x ULN and \<3 mg/dL for patients with Gilbert's disease
Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤3 x ULN
PT/INR/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 below:
Creatinine clearance for males = (140-age)(weight in kg)(72)(serum creatinine inmgdL⁄)
Creatinine clearance for females = (140-age)(weight in kg)(0.85)(72)(serum creatinine inmgdL⁄)
Negative pregnancy test done ≤7 days prior to registration, for persons of childbearing potential only
Willing to take light-protective measures during the study and for two weeks after their last dose of WSD0628
Provide written informed consent
Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
Willingness to provide mandatory tissue specimens for correlative research
Exclusion
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
Uncontrolled intercurrent illness including, but not limited to:
ongoing or active infection
symptomatic congestive heart failure
unstable angina pectoris
cardiac arrhythmia
or psychiatric illness/social situations that would limit compliance with study requirements
Any of the following cardiac criteria:
Marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>480 milliseconds (ms) (CTCAE Grade 1) using Fredericia's QT correction formula.
History of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT. Syndrome).
Use of concomitant medications that prolong the QT/QTc interval
History of myocardial infarction ≤6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Known coagulopathy increasing the risk of bleeding or history of clinically significant hemorrhage, including significant intracranial tumor related hemorrhage
Any of the following medications:
Enzyme-inducing anticonvulsants within two weeks of enrollment NOTE: Patients can be enrolled after a change to non-enzyme inducing anticonvulsants)
Patients taking more than 8 mg of dexamethasone per day (or equivalent steroid dose) at time of enrollment
Any of the following prior therapies:
Radiation therapy \<= 26 weeks prior to registration (including gamma tiles)
Chemotherapy, immunotherapy, or any investigational drug \<= four weeks prior to registration,
or carmustine (BCNU) or lomustine (CCNU) \<= six weeks prior to registration
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
History of hypersensitivity to active or inactive excipients of WSD0628 or drugs with a similar chemical structure or class to WSD0628
Refractory nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of WSD0628
Uncontrolled hypertension
History of severe brain-injury or stroke
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
What this trial measures
- Determine the maximum tolerated dose of WSD0628 in combination with radiation therapy for patients with recurrent high-grade glioma.4 weeks after last day of RT (up to 60 days)
Use Bayesian Optimal Interval (BOIN) design to inform dose escalation and de-escalation decisions and to ultimately determine the maximum tolerated dose level (MTD) of WSD0628 in patient population.
- Determine the recommended phase 2 dose of WSD0628 in combination with radiation therapy for patients with recurrent high-grade glioma.4 weeks after last day of RT (up to 60 days)
Evaluate biologic activity measures using rank-based desirability scores (RDS) generated for each of the dose levels to identify which of these scores best when looking jointly at toxicity and biologic activity. The rank-based desirability scores (RDS) for this BOIN12 design will be used to help identify the best dose