Clinical Trial Of The ATM-Inhibitor WSD0628 In Combination With Radiation Therapy For Recurrent Brain Tumors

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histological confirmation of glioblastoma, IDH-wildtype; or Grade 3 or 4, IDH1/2 mutant astrocytoma (2021 WHO classification).
  • Disease progression after previous treatment for glioma with radiation and chemotherapy.
  • Eligible for re-irradiation as a part of routine clinical care 3.1.6 ECOG Performance Status (PS) ≤ 2 (Appendix I).
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
  • Provide written informed consent.
  • Willing to return for follow-up (during the Active Monitoring Phase of the study).
  • Willing to provide tissue and blood samples for correlative research purposes (see Section 6).
  • Adequate organ and bone marrow function as defined by the following laboratory values obtained ≤14 days prior to registration:
    • Hemoglobin > 9.0 g/dL;
    • Leukocytes > 3.0 x 10^9/L;
    • Absolute neutrophil count > 1.5 x 10^9/L;
    • Platelets > 100 x 10^9/L;
    • INR < 1.5 x upper limit of normal (ULN)*;
    • aPTT < 1.5 x ULN;
    • Total bilirubin ≤ 1.5 x ULN and <3 mg/dL for patients with Gilbert’s disease;
    • AST (SGOT) & ALT (SGPT) ≤ 3 x ULN. i. Creatinine ≤ 1.5 x ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/minute.
  • Minimum life expectancy of at least 3 months.
  • Willing to take light-protective measures during the study and for two weeks after their last dose of WSD0628.
  • For patients enrolled on Part B2: Dose Expansion, Brain Tumor Penetration Cohort: plan for radiosurgery and surgical resection as part of routine clinical care.

Exclusion Criteria: 

  • < 18 years old. 
  • Pregnant. 

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/9/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

William Breen, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions