A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK-triggered Expansion Cohort

This study is testing an experimental drug called BDTX-1535 to see if it can safely stop the growth of certain aggressive brain tumors. It focuses on tumors with specific genetic changes, known as EGFR alterations, that help the cancer grow.

This trial is for people newly diagnosed with glioblastoma or those whose high-grade brain tumor has returned after previous treatments. You must be healthy enough for surgery and have a tumor that carries the specific genetic changes the drug is designed to target.

Participants will take the study drug, sometimes alongside standard radiation or chemotherapy, to see how well it reaches the brain. You will have regular check-ups, and the study will monitor your health closely to find the safest dose for the medication.

The study is currently recruiting patients in Chandler and Phoenix, Arizona. Because this is an early-stage trial, it is important to talk with your doctor to see if your specific tumor profile matches what researchers are looking for.