Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions
High Grade Glioma
About this trial
This is an interventional treatment trial for High Grade Glioma
Eligibility Criteria
Inclusion Criteria: Participants who have had a prior resection of diagnosed HGG (2021 WHO grade 3 and 4), defined as participants who have progressed on or following standard therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy. Adequate archival or biopsy tissue available for testing of EGFR alterations. Participants must have measurable disease preoperatively. Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale. Ability to swallow oral medications. Participant has adequate bone marrow and organ function Exclusion Criteria: Pregnancy or breastfeeding. Known allergic reactions to components of the BDTX-1535. Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis, as determined by the investigator. Known active systemic bacterial infection, fungal infection, or detectable viral infection . Significant cardiovascular disease. Symptomatic or radiographic leptomeningeal disease. Participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study . Concurrent use of prohibited medications.
Sites / Locations
- St. Joseph's Hospital and Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Recurrent high-grade glioma participants with EGFR alterations
Recurrent high-grade glioma participants with EGFR fusion