ERAS-801 for Glioblastoma or Gliosarcoma with EGFR Amplification or Mutation
This study is testing a drug called ERAS-801 for people with a type of brain cancer called glioblastoma or gliosarcoma. Specifically, it's for those whose cancer has a particular genetic change (IDH wildtype and EGFR amplification or mutation) and is either growing, has come back, or is newly diagnosed in older patients. Researchers want to see how ERAS-801 affects the cancer's use of sugar (measured by Fludeoxyglucose F-18, or FDG, uptake), how the body handles the drug, and if it can prevent the cancer from getting worse for at least six months. The study is currently recruiting about 50 participants aged 18 and older.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is not specified if it's a specific phase, but it aims to enroll 50 participants.
- What's involved
- Participants will undergo biospecimen collection (urine, blood, CSF), echocardiography (ECHO), brain MRI, and receive ERAS-801 orally. Fludeoxyglucose F-18 (FDG) will also be given.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures progression-free survival at 6 months, indicating follow-up for at least that duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
Recruiting
PHASE1Ages 18+InterventionalTreatmentJonsson Comprehensive Cancer CenterInvestigator-initiated
~50 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Biospecimen CollectionEchocardiography TestEGFR Inhibitor ERAS-801Fludeoxyglucose F-18Magnetic Resonance ImagingPositron Emission Tomography
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fludeoxyglucose F-18 (FDG) tumor uptake (Cohort A)
Measured over At baseline, prior to initiation of study treatment and after study treatment prior to surgery
+2 more outcomes measured
Conditions
Where it's being run
2 sites across 2 statesCalifornia1
New York1
Study leadership
- Phioanh Nghiemphu · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
COHORT A: Patients must be 18 years of age or older on the day of signing informed consent
COHORT A: Patients must have histologically proven surgically accessible World Health Organization (WHO) grade IV glioblastoma/gliosarcoma, which is progressive or recurrent following radiation therapy +/- chemotherapy
COHORT A: Patient tumor sample must have wild type IDH with evidence of EGFR mutation/amplification by Clinical Laboratory Improvement Act (CLIA)-certified laboratory assay. Patients with EGFR mutations in T790M or exon 20 will be excluded
COHORT A: Patients may have had no more than two prior recurrences
COHORT A: Patient must be able to tolerate MRIs. Pre-study enrollment MRIs must be available for central review, including at least the immediate pre-progression scan and the scan demonstrating progression. Patients must have measurable, by RANO, supratentorial contrast-enhancing progressive or recurrent high-grade glioma by MRI imaging within 28 days prior to enrollment
COHORT A: Patients must have recovered from severe toxicity of prior therapy. The following intervals from previous treatments are required to be eligible:
12 weeks from the completion of radiation
6 weeks from a nitrosourea chemotherapy
3 weeks from a non-nitrosourea chemotherapy
4 weeks from any investigational (not Food and Drug Administration \[FDA\]-approved) agents
4 weeks from the last treatment with bevacizumab
2 weeks from administration of a non-cytotoxic, FDA-approved agent other than bevacizumab (e.g., hydroxychloroquine, etc.)
1 week from the tumor treating fields
COHORT A: Patients must be undergoing surgery that is clinically indicated as determined by their care providers. Patients must be eligible for surgical resection according to the following criteria:
Expectation that the surgeon can resect at least 500 mg of tumor from enhancing tumor and 100 mg from non-enhancing tumor (if available) with low risk of inducing neurological injury
COHORT A: Paraffin embedded tissue must be available from initial surgical resection at diagnosis (prior to any treatment). The following amount of tissue is requested: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 30 FFPE unstained slides (5µm thick)
COHORT A: Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
COHORT A: Absolute neutrophil count (ANC) ≥ 1000/uL
COHORT A: Platelets ≥ 100,000/uL
COHORT A: 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
COHORT A: Creatinine ≤ 1 x upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 30 mL/min for participant with creatinine levels \> 1 x institutional ULN (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\])
Creatinine clearance (CrCl) should be calculated per institutional standard
COHORT A: Total bilirubin ≤ 1.5 x ULN unless with Gilbert's syndrome
COHORT A: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x ULN
COHORT A: International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
COHORT A: Patients must have left ventricular ejection fraction (LVEF) within normal institutional limits within 21 days of starting treatment
COHORT A: Patients must have a 12-lead electrocardiogram performed within 2 weeks of treatment start with Fridericia's formula-corrected QT interval (QTcF) =\< 450 msec
COHORT A: Patients must be able to provide written informed consent
COHORT A: Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose
COHORT A: Women of childbearing potential and men must agree to use adequate method of contraception for the duration of study participation and for at least 6 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after the last dose of study drug
COHORT A: Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, prostate, bladder or melanoma in situ. Patients with prior malignancies must be disease-free for \> three years
COHORT A: Patients must be able to swallow medication by mouth
COHORT B: Patients must be 18 years of age or older on the day of signing informed consent
COHORT B: Patients must have histologically proven WHO grade 4 glioblastoma/gliosarcoma, which is progressive or recurrent following radiation therapy +/- chemotherapy
COHORT B: Patient initial tumor sample must have wild type IDH with evidence of EGFR mutation/amplification by CLIA-certified laboratory assay. Patients with EGFR mutations in T790M or exon 20 will be excluded
COHORT B: Patients may have had no more than two prior recurrences
COHORT B: Patient must be able to tolerate MRIs. Pre-study enrollment MRIs must be available for central review, including at least the immediate pre-progression scan and the scan demonstrating progression. Patients must have measurable, by RANO, supratentorial contrast-enhancing progressive or recurrent high-grade glioma by MRI imaging within 14 days prior to enrollment
COHORT B: Patients must have recovered from severe toxicity of prior therapy. The following intervals from previous treatments are required to be eligible:
12 weeks from the completion of radiation
6 weeks from a nitrosourea chemotherapy
3 weeks from a non-nitrosourea chemotherapy
4 weeks from any investigational (not FDA-approved) agents
4 weeks from the last treatment with bevacizumab
2 weeks from administration of an anti-cancer, non-cytotoxic, FDA-approved agent other than bevacizumab (e.g., hydroxychloroquine, etc.)
1 week from the tumor treating fields device(s)
COHORT B: Paraffin embedded tissue must be available from initial surgical resection at diagnosis. The following amount of tissue is requested: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 30 FFPE unstained slides (5um thick).
COHORT B: Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
COHORT B: Absolute neutrophil count (ANC) ≥ 1000/uL
COHORT B: Platelets ≥ 100000/uL
COHORT B: Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/La
Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks
COHORT B: Creatinine \< 1.5 times ULN or measured or calculated creatinine clearance \> 30 mL/min for participant with creatinine levels \> 1.5 x institutional ULN (GFR can also be used in place of creatinine or CrCl)
Creatinine clearance (CrCl) should be calculated per institutional standard.
COHORT B: Total bilirubin ≤ 1.5 x ULN unless with Gilbert's syndrome
COHORT B: AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
COHORT B: International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
COHORT B: Patients must have left ventricular ejection fraction (LVEF) within normal institutional limits within 21 days of starting treatment
COHORT B: Patients must have a 12-lead electrocardiogram performed within 2 weeks of treatment start with QTcF ≤ 450 msec
COHORT B: Patients must be able to provide written informed consent
COHORT B: Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose
COHORT B: Women of childbearing potential and men must agree to use adequate method of contraception for the duration of study participation and for at least 6 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after the last dose of study drug
COHORT B: Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, prostate, bladder or melanoma in situ. Patients with prior malignancies must be disease-free for \> three years
COHORT B: Patients must be able to swallow medication by mouth
COHORT C: Patients must be ≥ 70 years of age at the time of informed consent, with a life expectancy \> 8 weeks
COHORT C: Patients must have histologically proven newly diagnosed WHO grade 4 glioblastoma/gliosarcoma
COHORT C: Patient initial tumor sample must have wild type IDH with evidence of EGFR mutation/amplification by CLIA-certified laboratory assay. Patients with EGFR mutations in T790M or exon 20 will be excluded
COHORT C: Patient must be able to tolerate MRIs. Pre-study enrollment MRIs must be available for central review, including the pre-surgery MRI and the immediate post-diagnostic surgery MRI. The immediate postoperative MRI is preferred but not required to occur within 96 hours of surgery. The patient must also have a baseline MRI within 14 days prior to enrollment. Craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis. Enrollment is at least 2-4 weeks from prior surgery (if time is needed to be extended, PI approval needed)
COHORT C: Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
COHORT C: Absolute neutrophil count (ANC) ≥ 1000/uL
COHORT C: Platelets ≥ 100000/uL
COHORT C: Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/La
Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks
COHORT C: Creatinine \< 1.5 times ULN OR measured or calculated creatinine clearance \> 30 mL/min for participant with creatinine levels \> 1.5 x institutional ULN (GFR can also be used in place of creatinine or CrCl)
Creatinine clearance (CrCl) should be calculated per institutional standard
COHORT C: Total bilirubin ≤ 1.5 x ULN unless with Gilbert's syndrome
COHORT C: AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
COHORT C: International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
COHORT C: Paraffin embedded tissue must be available from initial surgical resection at diagnosis. The following amount of tissue is requested: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 30 FFPE unstained slides (5um thick)
COHORT C: Patients must have left ventricular ejection fraction (LVEF) within normal institutional limits within 21 days of starting treatment
COHORT C: Patients must have a 12-lead electrocardiogram performed within 2 weeks of treatment start with QTcF ≤ 450 msec
COHORT C: Patients must be able to provide written informed consent
COHORT C: Men treated or enrolled on this protocol who has a partner with reproductive potential must agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after the last dose of study drug
COHORT C: Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, prostate, bladder or melanoma in situ. Patients with prior malignancies must be disease-free for \> three years
COHORT C: Patients must be able to swallow medication by mouth
Exclusion
COHORT A: Participants may not be receiving any other investigational agents
COHORT A: Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ERAS-801 are ineligible
COHORT A: 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)
COHORT A: Participants on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol. Patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs. Patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of ERAS-801
COHORT A: Participants must not have evidence of significant hematologic, renal, or hepatic dysfunction
COHORT A: Participants must not have evidence of significant intracranial hemorrhage
COHORT A: Participants with clinically significant cardiovascular disease including, but not limited to:
Myocardial infarction or unstable angina within the 6 months prior to the first dose of study drug
Clinically significant cardiac arrhythmia
Prolonged QTcF \> 450 ms
Uncontrolled (persistent) hypertension: systolic blood pressure \> 180 mmHg; diastolic blood pressure \> 100 mmHg
Congestive heart failure (New York Heart Association class III-IV)
Use of pacemaker
Pulmonary embolism \< 30 days
COHORT A: Participants with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible
COHORT A: Pregnant women are excluded from this study because ERAS-801 has unknown potential for teratogenic or abortifacients effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ERAS-801, breastfeeding should be discontinued if the mother is treated with ERAS-801
COHORT A: Participants currently using or anticipating need to use drugs, food, or herbal supplements known to be strong or moderate inducers or inhibitors of CYP3A4, CYP2C8, and/or CYP2D6 and P-glycoprotein (P-gp) substrates may be enrolled if they have been off the substrates for at least 10 days or 5 half-lives prior to the first dose of ERAS 801, whichever is shorter
COHORT A: Participants who have acute or currently active/requiring anti-viral therapy hepatic or biliary disease are ineligible (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases from the primary brain tumor, or stable chronic liver disease per investigator assessment)
COHORT A: Patients with gastrointestinal conditions that may affect reliable administration/absorption of medications including difficulty swallowing/unable to swallow pills; malabsorption syndrome; refractory nausea and vomiting, chronic gastrointestinal (GI) disease or previous significant bowel resection with clinically significant sequelae are ineligible
COHORT A: Participants receiving P-gp inhibitors are ineligible
COHORT A: Patients who have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial are ineligible
COHORT B: Participants may not be receiving any other investigational agents
COHORT B: Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ERAS-801 are ineligible
COHORT B: 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 PI
COHORT B: Participants on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol. Patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs. Patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of ERAS-801
COHORT B: Participants must not have evidence of significant hematologic, renal, or hepatic dysfunction
COHORT B: Participants must not have evidence of significant intracranial hemorrhage
COHORT B: Participants with clinically significant cardiovascular disease including, but not limited to:
Myocardial infarction or unstable angina within the 6 months prior to the first dose of study drug
Clinically significant cardiac arrhythmia
Prolonged QTcF\> 450 ms
Uncontrolled (persistent) hypertension: systolic blood pressure \> 180 mmHg; diastolic blood pressure \> 100 mmHg
Congestive heart failure (New York Heart Association class III-IV)
Use of pacemaker
Pulmonary embolism \< 30 days
COHORT B: Participants with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible
COHORT B: Pregnant women are excluded from this study because ERAS-801 has unknown potential for teratogenic or abortifacients effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ERAS-801, breastfeeding should be discontinued if the mother is treated with ERAS-801
COHORT B: Participants currently using or anticipating need to use drugs, food, or herbal supplements known to be strong or moderate inducers or inhibitors of CYP3A4, CYP2C8, and/or CYP2D6 and P-gp substrates may be enrolled if they have been off the substrates for at least 10 days or 5 half-lives prior to the first dose of ERAS 801, whichever is shorter
COHORT B: Participants who have acute or currently active/requiring anti-viral therapy hepatic or biliary disease are ineligible (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases from the primary brain tumor, or stable chronic liver disease per investigator assessment)
COHORT B: Patients with gastrointestinal conditions that may affect reliable administration/absorption of medications including difficulty swallowing/unable to swallow pills; malabsorption syndrome; refractory nausea and vomiting, chronic gastrointestinal (G
What this trial measures
- Fludeoxyglucose F-18 (FDG) tumor uptake (Cohort A)At baseline, prior to initiation of study treatment and after study treatment prior to surgery
FDG positron emission tomography (PET), as measured by median normalized FDG standardized uptake value (SUV) within the contrast enhancing tumor, will be compared to estimate the change in FDG uptake in the tumor. Analyses will be descriptive, summarizing changes with confidence intervals and exploring correlations; no formal hypothesis testing is planned.
- Pharmacokinetics (PK) dose modification (Cohort B)At day 1 and day 15
Will evaluate the effect of 120 mg twice daily dosing on corrected QT interval (QTc) relative to maximum concentration compared with historical 240 mg once-daily data. PK data and triplicate electrocardiograms will be summarized descriptively, with QTc analyzed as a continuous change.
- 6 month progression free survival (Cohort C)At 6 months
Will be summarized as a proportion with corresponding 95% exact confidence intervals. Nominal exact two-sided p-values will be presented, testing EGFR inhibitor ERAS-801 against a fixed 5% null rate. Simon's minimax two-stage design will be used for conducting the trial.