Actively Recruiting
ERAS-801 for Resectable and Progressive or Recurrent IDH Wildtype Grade IV Glioblastoma or Astrocytoma With EGFR Amplification or Mutation
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-04-07
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating ERAS-801, an EGFR inhibitor that can reach the central nervous system, for treating adults with resectable, progressive or recurrent IDH wildtype grade IV glioblastoma or astrocytoma that have EGFR amplification or mutation. Glioblastoma is a common and aggressive brain cancer with poor survival despite standard treatments like surgery, radiation, and chemotherapy. This phase Ib trial focuses on assessing ERAS-801's safety, side effects, and its impact on tumor glucose use and cell death mechanisms. Participants receive ERAS-801 orally once daily for 8 to 14 days before scheduled surgery to remove the tumor. After surgery, treatment resumes within 28 days, with ERAS-801 given daily for 28-day cycles, continuing unless the disease worsens or side effects become unacceptable. During the study, patients undergo various procedures including echocardiography, urine and blood tests, brain MRI scans, cerebrospinal fluid collection during surgery, and FDG PET scans to monitor the treatment effects and disease status. Throughout the trial, participants are closely monitored for adverse events from enrollment until 30 days after the last dose. Researchers measure tumor glucose uptake, metabolic changes in the tumor, ERAS-801 levels in plasma, cerebrospinal fluid and tumor tissue, and other biomarkers linked to treatment response. After completing treatment, patients have follow-up visits every two months until disease progression or death, with further monitoring every 12 weeks if the disease progresses, continuing until withdrawal or trial end. The study aims to better understand ERAS-801's effects and safety in this patient group.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years of age or older on the day of signing informed consent
- Have histologically proven surgically accessible WHO grade IV glioblastoma/astrocytoma that is progressive or recurrent after radiation therapy +/- chemotherapy
- Tumor must have wild type IDH with EGFR mutation/amplification confirmed by CLIA-certified assay
- No more than two prior recurrences
- Able to tolerate MRIs with measurable supratentorial progressive or recurrent tumor by MRI within 7 days before treatment
- Recovered from severe toxicity of prior therapies with specified minimum intervals from last treatments
- Undergoing clinically indicated surgery with expected tumor resection of at least 500 mg from enhancing tumor and 100 mg from non-enhancing tumor
- Available paraffin embedded tissue from initial resection
- Karnofsky performance status ≥ 60%
- Absolute neutrophil count ≥ 1000/uL
- Platelets ≥ 100,000/uL
- Hemoglobin ≥ 9.0 g/dL without recent transfusion or erythropoietin
- Creatinine ≤ 1 x ULN or creatinine clearance ≥ 30 mL/min
- Total bilirubin ≤ 1.5 x ULN unless Gilbert's syndrome
- AST and ALT ≤ 3 x ULN
- INR or PT/aPTT ≤ 1.5 x ULN unless on anticoagulants within therapeutic range
- Left ventricular ejection fraction within normal limits within 21 days before treatment
- 12-lead ECG with QTcF < 450 msec within 2 weeks before treatment
- Able to provide written informed consent
- Women of childbearing potential must have negative pregnancy test and agree to contraception; men must agree to contraception
- No concurrent malignancy except certain treated skin or carcinoma in situ cancers
- Able to swallow medication by mouth
You will not qualify if you...
- Receiving any other investigational agents
- History of allergic reactions to compounds similar to ERAS-801
- Prior therapy with EGFR inhibitors
- Using enzyme-inducing anti-epileptic drugs or not off them for at least 10 days before dosing
- Significant hematologic, renal, or hepatic dysfunction
- Significant intracranial hemorrhage
- Clinically significant cardiovascular disease including recent myocardial infarction, arrhythmia, prolonged QTcF > 450 ms, uncontrolled hypertension, heart failure class III-IV, pacemaker use, or recent pulmonary embolism
- Uncontrolled intercurrent illness or psychiatric/social conditions limiting study compliance
- Pregnancy or breastfeeding
- Use or anticipated use of strong/moderate inducers or inhibitors of CYP3A4, CYP2C8, CYP2D6, or P-gp substrates within 10 days before enrollment
- Acute or active hepatic/biliary disease requiring antiviral therapy except certain stable conditions
- Gastrointestinal conditions affecting medication absorption or swallowing
- Receiving P-gp inhibitors
- Known psychiatric or substance abuse disorders interfering with trial cooperation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 to 14 days
Participants take ERAS-801 once daily orally for 8 to 14 days before undergoing scheduled surgical tumor resection. They also undergo urine, blood, and CSF sample collection, echocardiography (ECHO), brain MRI, and FDG PET scans during this period.
Multiple visits including 1 surgical visit and several imaging and sample collection visits
Duration - Surgery day plus immediate recovery
Participants undergo scheduled surgical tumor resection with cerebrospinal fluid (CSF) collection at the time of surgery.
1 surgical visit
Duration - 28-day cycles repeated until disease progression or unacceptable toxicity
Starting within 28 days after surgery, participants take ERAS-801 orally once daily on days 1-28 of each 28-day cycle. Treatment continues in repeated cycles without disease progression or unacceptable toxicity. Participants continue to undergo ECHO, urine and blood sample collections, and brain MRI throughout treatment.
Visits on days 1 and 28 of each cycle, plus imaging and sample collection visits as scheduled
Duration - Up to several years until death, withdrawal, or study end
After completing study treatment, participants are followed up at 30 days, then every 2 months up to disease progression, death, or study end. Those with disease progression have follow-up visits every 12 weeks until death, withdrawal, or study end.
Follow-up visits every 2 months or every 12 weeks depending on disease status
Trial Site Locations
Total: 1 location
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
Q
Quan Li
E
Emese Filka
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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