OncoMatch/Clinical Trials/NCT07089641
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
Is NCT07089641 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies EGFR Inhibitor ERAS-801 for glioblastoma.
Treatment: EGFR Inhibitor ERAS-801 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
wild type IDH
Required: EGFR amplification
evidence of EGFR mutation/amplification by Clinical Laboratory Improvement Act (CLIA)-certified laboratory assay
Required: EGFR mutation
evidence of EGFR mutation/amplification by Clinical Laboratory Improvement Act (CLIA)-certified laboratory assay
Excluded: EGFR t790m
Patients with EGFR mutations in T790M or exon 20 will be excluded
Excluded: EGFR exon 20 mutation
Patients with EGFR mutations in T790M or exon 20 will be excluded
Disease stage
Required: Stage IV (other)
Grade: 4 (WHO)
WHO grade IV glioblastoma/gliosarcoma
Prior therapy
Cannot have received: EGFR inhibitor
Exception: If tumor resection after completing this treatment still shows EGFR amplification, patient might still be eligible and should be discussed with the principal investigator (PI)
Participants with prior therapy with EGFR inhibitors such as EGFR kinase inhibitors or other EGFR-targeted agents that have the potential to deplete the tumor of EGFR-amplified or EGFR mutant cell populations and confound the evaluation of ERAS-801 effects on participants are ineligible. If a participant had received previous treatment with EGFR-targeted agents but tumor resection after completing this treatment still shows EGFR amplification, patient might still be eligible and should be discussed with the principal investigator (PI)
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1000/uL; Platelets ≥ 100,000/uL; Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks)
Kidney function
Creatinine ≤ 1 x ULN OR measured or calculated creatinine clearance ≥ 30 mL/min for participant with creatinine levels > 1 x institutional ULN (GFR can also be used in place of creatinine or CrCl)
Liver function
Total bilirubin ≤ 1.5 x ULN unless with Gilbert's syndrome; AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
Cardiac function
Left ventricular ejection fraction (LVEF) within normal institutional limits within 21 days of starting treatment; 12-lead electrocardiogram within 2 weeks of treatment start with QTcF ≤ 450 msec
Total bilirubin ≤ 1.5 x ULN unless with Gilbert's syndrome; AST (SGOT) and ALT (SGPT) ≤ 3 x ULN; Creatinine ≤ 1 x ULN OR measured or calculated creatinine clearance ≥ 30 mL/min for participant with creatinine levels > 1 x institutional ULN (GFR can also be used in place of creatinine or CrCl); Absolute neutrophil count (ANC) ≥ 1000/uL; Platelets ≥ 100,000/uL; Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks); Left ventricular ejection fraction (LVEF) within normal institutional limits within 21 days of starting treatment; 12-lead electrocardiogram within 2 weeks of treatment start with QTcF ≤ 450 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA / Jonsson Comprehensive Cancer Center · Los Angeles, California
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07089641 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior EGFR inhibitor disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 wild-type is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR amplification is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR mutation is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR t790m is an exclusion criterion.
Are patients with EGFR alterations eligible?
No. EGFR exon 20 mutation is an exclusion criterion.
What disease stage is eligible?
Stage IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages