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 (NCT07089641)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (85 items) and avoid the listed exclusions (41 items).
Location: UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- COHORT A: Participants may not be receiving any other investigational agents
- COHORT A: Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ERAS-801 are ineligible
- COHORT A: Participants with prior therapy with EGFR inhibitors such as EGFR kinase inhibitors or other EGFR-targeted agents that have the potential to deplete the tumor of EGFR-amplified or EGFR mutant cell populations and confound the evaluation of ERAS-801 effects on participants are ineligible. If a participant had received previous treatment with EGFR-targeted agents but tumor resection after completing this treatment still shows EGFR amplification, patient might still be eligible and should be discussed with the principal investigator (PI)
- COHORT A: Participants on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol. Patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs. Patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of ERAS-801
- COHORT A: Participants must not have evidence of significant hematologic, renal, or hepatic dysfunction
- COHORT A: Participants must not have evidence of significant intracranial hemorrhage
- COHORT A: Participants with clinically significant cardiovascular disease including, but not limited to:
- Myocardial infarction or unstable angina within the 6 months prior to the first dose of study drug
- Clinically significant cardiac arrhythmia
- Prolonged QTcF \> 450 ms
- Uncontrolled (persistent) hypertension: systolic blood pressure \> 180 mmHg; diastolic blood pressure \> 100 mmHg
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California
- Memorial Sloan Kettering Cancer Center — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.