Recruiting

Phase 1

WSD0628 & Radiation TherapyATM-Inhibitor WSD0628 in Combination With Radiation Therapy for Treatment of Recurrent High-Grade Glioma

Sponsor:

Mayo Clinic

Code:

NCT05917145

Conditions

Glioblastoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

WSD0628

Study Details

Brief summary:

The purpose of this study is to test WSD0628 in combination with radiation therapy for recurrent brain tumors.

Conditions

Glioblastoma

Study ID

NCT05917145

Start date

Jan 17, 2024

Status verified date

Apr, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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

Study Design

Enrollment

94 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A (Dose Escalation)

WSD0628 treatment should be started the day before radiation therapy starts (Day 1). Radiation therapy is given for 10 consecutive business days (Day 2-15, not including weekends and holidays), and WSD0628 will only be given on those 10 consecutive business days ≥30 minutes but ≤2 hours before radiation.

experimental: Group B (Dose Expansion)

experimental: Group C (Tumor Penetrance Treatments)

One treatment of WSD0628 will be given prior to radiation and surgical resection will be performed on the same day. The two doses given will be determined by Group A and Group B. Patients will be randomized in a 1:1 fashion.

Dose level 1: minimally radiosensitizing concentration of WSD0628 will be achieved.
Dose level 2: selected based on a prediction that a maximally radiosensitizing concentration of WSD0628 will be achieved.

This portion of the study will open after Group A (Dose Escalation) is complete. This portion of the study will open to patients with recurrent high-grade glioma to further evaluate the efficacy, safety, tolerability, pharmacokinetics and biological activity of WSD0628 when combined with radiation therapy in specific patient subgroups

Interventions

WSD0628

A non-toxic compound and inhibits the DNA damage response associated with radiation therapy. • WSD-0628 radio sensitizes Glioblastoma cells.

Primary outcome measure

Determine the maximum tolerated dose of WSD0628 in combination with radiation therapy for patients with recurrent high-grade glioma. [ Time Frame: 4 weeks after last day of RT (up to 60 days) ]
Determine the recommended phase 2 dose of WSD0628 in combination with radiation therapy for patients with recurrent high-grade glioma. [ Time Frame: 4 weeks after last day of RT (up to 60 days) ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Willilam G. Breen, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-21.