MC220712 Phase 0/I Clinical Trial of the ATM-Inhibitor WSD0628 in Combination With Radiation Therapy for Recurrent High-Grade Glioma
Mayo Clinic
Summary
The purpose of this study is to test WSD0628 in combination with radiation therapy for recurrent brain tumors.
Description
High grade gliomas are the most common primary brain tumor in adults. Despite aggressive treatment including surgery, chemotherapy, and radiation, these tumors have a dismal prognosis. Following a radiation therapy, almost 80% of them recur locally. The focus of this project is the development of a radiation sensitizer (a small molecule ATM inhibitor, WSD0628) with the goal to enhance the efficacy of radiation therapy. The first step will be to establish a pre-clinical PK→PD→efficacy model to describe WSD0628 plasma and tumor concentrations associated with robust ATM inhibition and radiosensit…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 laborato…
Interventions
- DrugWSD0628
A non-toxic compound and inhibits the DNA damage response associated with radiation therapy. • WSD-0628 radio sensitizes Glioblastoma cells.
Location
- Mayo Clinic in RochesterRochester, Minnesota