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Testing the drug BDTX-1535 in gliomas with EGFR changes

Original title: 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

How far along is this research?

This is a trial that is enrolling or has been updated. It is not a finding yet.

This is an early test in people to see if the drug can be given safely.

Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.

The trial team last updated this record on . Always check the trial page for the latest.

The short version

This trial tests a new drug for brain tumors that have changes in a protein called EGFR.

Who this trial is for. This trial is for people whose high-grade glioma: A tumor that starts in the glial cells. Those are the support cells of the brain and spinal cord. Gliomas are given a grade from 1 to 4. The grade says how the tumor is expected to act. See the glossary has come back. It is also for people with newly diagnosed glioblastoma: A glioma that is given grade 4. Grade 4 is the highest grade there is. The tumor grows fast. Treatment usually starts soon after it is found. It often means surgery, and then radiation and chemotherapy. See the glossary. Their tumor must have EGFR changes. It tests a drug called BDTX-1535, which was made to block a growth signal. For some newly diagnosed people, the plan also includes the usual radiation treatment.

Where it stands. The trial is checking how the drug moves through the body. It is also looking for a dose that can be given safely. The trial has not reported results.

What this means, and what it doesn't

What it could mean: Some people with EGFR changes in their tumor may fit a trial like this. If that may be you, you can ask your care team about it. Your team can explain the risks and whether it makes sense for you.

What it doesn't mean: This does not mean the drug works. A trial is a test, not a proven treatment. Being in a trial is not a guarantee that it will help you. It is not a promise of a cure.

Source: ClinicalTrials.gov, October 16, 2026 · Read the original

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