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

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.

Conditions

• Glioblastoma
• Glioblastoma, IDH-Wildtype
• Gliosarcoma
• Recurrent Glioblastoma, IDH-Wildtype
• Recurrent Gliosarcoma
• Resectable Glioblastoma

Interventions

PROCEDURE

Surgical Procedure

Undergo surgical resection

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Phioanh Nghiemphu · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-28

Primary Completion

2027-07-30

Completion

2028-07-30

FDA Drug

Yes

Countries

• United States

Study Locations