RecruitingPhase 1NCT07089641

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

A Phase Ib Open Label Clinical Trial to Evaluate the Safety and Efficacy of ERAS-801 in Surgically Accessible Recurrent Glioblastoma Patients With EGFR Amplification or Mutation (ERAS801-SARG)


Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

10 participants

Start Date

Jul 28, 2025

Study Type

INTERVENTIONAL

Conditions

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 astrocytoma that can be removed by surgery (resectable) and that is growing, spreading, or getting worse (progressive) or that has come back after a period of improvement (recurrent). 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (ERAS801-SARG) tests a drug called ERAS-801 in people with recurrent or progressive glioblastoma or high-grade brain cancer (astrocytoma) that has specific genetic features — an EGFR amplification or mutation. Participants will receive ERAS-801 as part of their treatment before and after tumor removal surgery. **You may be eligible if...** - You are 18 or older - You have a confirmed grade IV glioblastoma or astrocytoma that has progressed or come back after standard treatment (radiation ± chemotherapy) - Your tumor has an EGFR amplification or mutation - Your tumor is surgically accessible - You have adequate organ function and performance status **You may NOT be eligible if...** - You have certain prior EGFR-targeting therapy - Your tumor cannot be safely removed with surgery - You have uncontrolled medical conditions or active infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBiospecimen Collection

Undergo urine, blood, and CSF sample collection

PROCEDUREEchocardiography Test

Undergo ECHO

DRUGEGFR Inhibitor ERAS-801

Given PO

OTHERFludeoxyglucose F-18

Given FDG

PROCEDUREMagnetic Resonance Imaging

Undergo brain MRI

PROCEDUREPositron Emission Tomography

Undergo FDG PET

PROCEDURESurgical Procedure

Undergo surgical resection


Locations(1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07089641


Related Trials