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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo urine, blood, and CSF sample collection
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• EGFR Inhibitor ERAS-801 — DRUG
  Given PO
• Fludeoxyglucose F-18 — OTHER
  Given FDG
• Magnetic Resonance Imaging — PROCEDURE
  Undergo brain MRI
• Positron Emission Tomography — PROCEDURE
  Undergo FDG PET
• Surgical Procedure — PROCEDURE
  Undergo surgical resection

Study Details

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.

Key Dates

First listed

Jul 28, 2025

Start date

Jul 28, 2025

Status verified

Jun 2026

Primary completion

Jul 30, 2027

Completion

Jul 30, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A (ERAS-801)
  Patients receive ERAS-801 PO QD for 8-14 days prior to undergoing scheduled surgical resection. Starting no more than 28 days after surgery, patients then receive ERAS-801 PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO, urine and blood sample collection and brain MRI throughout the study. Additionally, patients undergo CSF sample collection at the time of surgery and FDG PET on study.
• Experimental: Cohort B (ERAS-801)
  After first or second recurrence, patients receive ERAS-801 PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO, urine and blood sample collection and brain MRI and FDG-PET throughout the study.
• Experimental: Cohort C (ERAS-801)
  Within 2-4 weeks of the last tumor surgery, newly diagnosed patients receive ERAS-801 PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO, urine and blood sample collection and brain MRI and FDG-PET throughout the study.

Primary Outcome Measure

Fludeoxyglucose F-18 (FDG) tumor uptake (Cohort A) [ Time Frame: At baseline, prior to initiation of study treatment and after study treatment prior to surgery ]

Locations (2)

Find similar trials in Los Angeles, CA

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