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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT07089641
Phase
PHASE1
Status
Recruiting
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Conditions

  • IDH Wildtype Glioblastoma
  • IDH Wildtype Recurrent Glioblastoma
  • Recurrent Astrocytoma
  • Resectable Astrocytoma
  • 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 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.

Key Dates

Start date
Jul 28, 2025
Status verified
Jul 2025
Primary completion
Jul 30, 2027
Completion
Jul 30, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (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.

Primary Outcome Measure

Fludeoxyglucose F-18 (FDG) tumor uptake [ Time Frame: Time Frame (Day 1 to Day 8 during pre-surgery treatment);at Baseline prior to Day 1 of pre-surgery study treatment & on Day 8 of Pre-surgery study treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Emese Filka
[email protected]
310-825-1416
Quan Li
[email protected]
310-825-1416
Phioanh Nghiemphu, MD (PRINCIPAL_INVESTIGATOR)

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By research site
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