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About the High-Grade Glioma Clinical Trial

The Ivy Brain Tumor Center at Barrow Neurological Institute, a nonprofit translational research program, is conducting a Phase 0/1 clinical trial to evaluate BDTX-1535, an experimental drug intended to block a key growth signal in patients with recurrent high-grade glioma, driven by EGFR (Epidermal Growth Factor Receptor) genetic aberrations.

This Phase 0/1 clinical trial will assess the drug’s ability to cross the blood-brain barrier in patients with EGFR-altered gliomas, and measure tumor response to the drug.

The main goal of this study is to evaluate how much BDTX-1535 accumulates in the tumor tissue of participants. Patients who demonstrate adequate drug penetration may be eligible for continued treatment within the trial’s expansion phase.

High-Grade Glioma Trial Details

Study Status


Treatment Agent(s)



High-Grade Glioma

ClinicalTrials.Gov Identifier
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You may be eligible if:

  • You are 18 years or older
  • You have a histologically diagnosed high-grade glioma (WHO grade 3 or 4), and a biopsy confirmed a recurrence.
  • You received previous first-line treatment with standard-of-care radiotherapy and temozolomide.
  • You have sufficient archived or biopsy tissue for testing EGFR alterations or fusions.

How it works

Once enrolled, a patient receives a very small exposure to the experimental therapy days before a planned operation to remove their tumor.

This exposure is enough that when we remove the tumor, our team of experts can ask an important question: Did the treatment penetrate the tumor?

If the answer is yes, the patient may move forward with receiving a full dose of the treatment in an expansion arm of the trial.

Alternatively, if the treatment has no effect on the tumor, the patient can enroll in another clinical trial without losing time or receiving ineffective treatment.

Contact an Ivy Navigator

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Am I eligible?

Submit a free trial screening request today to learn if you may qualify for any of our studies.

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