Phase 01 Study of BDTX-1535 for Recurrent High-Grade Glioma and Newly Diagnosed Glioblastoma with EGFR Alterations or Fusions to Assess Drug Penetration and Safety

What this Trial Is About

Researchers are evaluating an investigational drug called BDTX-1535 in people with recurrent high-grade glioma HGG and newly diagnosed glioblastoma nGBM who have specific changes in a protein called EGFR found only in their tumors. This study includes a Phase 0 part to assess how the drug behaves in the body and a Phase 1 part to find the safe dose and treatment regimen, some of which include standard radiotherapy. The study aims to understand if BDTX-1535 can be safely given to these participants based on their tumors genetic profile. In the Phase 0 component, participants receive BDTX-1535 before planned tumor removal surgery, with doses varying by group and timing designed to measure drug levels in blood, tumor, and cerebrospinal fluid. After surgery, those showing specific responses continue in the Phase 1 expansion, receiving daily BDTX-1535 in 28-day cycles, sometimes combined with radiation therapy or temozolomide depending on tumor characteristics. Treatment continues until disease progression, unacceptable side effects, or other reasons such as withdrawal or study end. Participants will have surgery with sample collection for drug level and protein activity analysis, followed by regular treatment visits during Phase 1. Researchers will monitor safety, side effects, and lab values, along with progression-free and overall survival for up to 12 months after surgery. The study includes frequent assessments and safety follow-up to evaluate how the drug interacts with tumors and its tolerability over time.

A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (rHGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions