A Phase Ib Open Label Clinical Trial to Evaluate the Safety and Efficacy of ERAS-801 in Recurrent Glioblastoma or Elderly Newly Diagnosed Glioblastoma Patients With EGFR Amplification and/or Mutation (ERAS-801-3.0)

Summary

This phase Ib trial tests the safety and side effects of ERAS-801 in treating patients with isocitrate dehydrogenase (IDH) wildtype, epidermal growth factor receptor (EGFR) amplified or mutated grade IV glioblastoma or gliosarcoma that can be removed by surgery (resectable) and that is growing, spreading, or getting worse (progressive), that has come back after a period of improvement (recurrent) or that is newly diagnosed in an elderly patient. Glioblastoma is the most common brain cancer in adults and survival rates remain poor despite treatment including surgery, radiation and chemotherapy. EGFR is a protein found on the surface of some cells, to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of tumor cells, so these cells may divide excessively in the presence of epidermal growth factor. ERAS-801, an EGFR inhibitor that can penetrate the central nervous system, binds to the tumor cells that express EGFR and may help shrink or slow the growth of the tumor cells.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Procedure
  Biospecimen Collection

  Undergo urine, blood, and CSF sample collection

• Procedure
  Echocardiography Test

  Undergo ECHO

• Drug
  EGFR Inhibitor ERAS-801

  Given PO

• Other
  Fludeoxyglucose F-18

  Given FDG

• Procedure
  Magnetic Resonance Imaging

  Undergo brain MRI

• Procedure
  Positron Emission Tomography

  Undergo FDG PET

• Procedure
  Surgical Procedure

  Undergo surgical resection

Locations (2)