Clinical Trial

ERAS-801 for the Treatment of Resectable and Progressive or Recurrent or Elderly Newly Diagnosed IDH Wildtype Grade IV Glioblastoma or Gliosarcoma With an EGFR Amplification or Mutation, ERAS801-SARG Trial

Recruiting Phase 1
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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.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-07-21
notable Enrollment increased: 10 -> 50 participants 2026-07-21
minor Trial arms changed: 1 -> 3 2026-07-21
Trial Details
NCT Number NCT07089641
Lead Sponsor Jonsson Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Glioblastoma, Glioblastoma, IDH-Wildtype, Gliosarcoma, Recurrent Glioblastoma, IDH-Wildtype, Recurrent Gliosarcoma, Resectable Glioblastoma
Enrollment 50 participants
Start Date 2025-07-28
Primary Completion 2027-07-30 (estimated)
Study Completion 2028-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-20