A Phase 1 interventional study of Biospecimen Collection and Echocardiography Test in Glioblastoma, Glioblastoma, IDH-Wildtype and Gliosarcoma, sponsored by Jonsson Comprehensive Cancer Center. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Jonsson Comprehensive Cancer Center · Phase 1, Interventional, and Treatment
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.
PRIMARY OBJECTIVE:
I. To evaluate the glucose utilization in the tumor from the glioblastoma patients treated with EGFR inhibitor ERAS-801 (ERAS-801). (Cohort A) II. To evaluate the changes in maximum concentration (Cmax) at dose optimized ERAS-801 correlating with corrected QT interval (QTc) prolongation. (Cohort B) III. To evaluate the tolerability and efficacy of ERAS-801 recommended phase 2 dose (RP2D) in patients ≥ 70 years of age with newly diagnosed glioblastoma. (Cohort C) IV. To evaluate the 6 month progression free survival (PFS6) and response rate (RR) of ERAS-801 in patients ≥ 70 years of age with newly diagnosed glioblastoma. (Cohort C)
SECONDARY OBJECTIVES:
I. To evaluate the pharmacokinetic (PK) profile in plasma, cerebrospinal fluid (CSF), and tumor tissue of ERAS-801 in recurrent glioblastomas. (Cohort A) II. To evaluate the pharmacodynamic (PD) impact of ERAS-801 treatment in recurrent glioblastomas. (Cohort A) III. To evaluate whether glycolytic index (GI) measured by fludeoxyglucose F-18 (FDG)-positron emission tomography (PET) and metabolic magnetic resonance imaging (MRI) correlates with clinical responses in recurrent glioblastomas treated with ERAS-801. (Cohort A) IV. To evaluate whether potential of hydrogen (pH)-weighted chemical exchange saturation transfer (CEST)-spin-and-gradient echo (SAGE)-echoplanar imaging (EPI) contrast measured by metabolic MRI correlates with clinical responses in recurrent glioblastomas treated with ERAS-801. (Cohort A) V. To evaluate the influence of ERAS-801 treatment on the apoptotic machinery in recurrent glioblastoma. (Cohort A) VI. To evaluate the safety and tolerability of ERAS-801 recommended phase 2 dose (RP2D) in recurrent glioblastoma. (Cohort A) VII. To evaluate the steady state of dose optimized ERAS 801. (Cohort B) VIII. To evaluate the pharmacokinetic (PK) profile in plasma of dose optimized ERAS-801 in recurrent glioblastomas. (Cohort B) IX. To evaluate the safety and tolerability of ERAS-801 optimized dosing in recurrent glioblastoma. (Cohort B) X. To evaluate the glucose utilization in the tumor from the glioblastoma patients treated with ERAS-801 at optimized dosing. (Cohort B) XI. To evaluate the pharmacokinetic (PK) profile in plasma of ERAS-801 in patients ≥ 70 years of age with newly diagnosed glioblastomas. (Cohort C) XII. To evaluate the glucose utilization in the tumor from the glioblastoma patients ≥ 70 years of age treated with ERAS-801. (Cohort C)
EXPLORATORY OBJECTIVES:
I. To evaluate the associations between exploratory biomarkers, clinical outcomes, and adverse events which include:
Ia. Estimating the efficacy of ERAS-801 through 6 month PFS6, progression free survival (PFS), and overall survival (OS) as defined by modified Response Assessment in Neuro-Oncology criteria (mRANO)/Response Assessment in Neuro-Oncology criteria (RANO) 2.0; Ib. Exploring whether glycolytic index (GI) and pH-weighted CEST-SAGE-EPI contrast correlates with clinical responses; Ic. Exploring whether there are alterations of key glycolytic enzymes and/or other transcriptional changes linked to EGFR occur with ERAS-801 treatment; Id. Exploring whether there are changes in percent of tumor cells that have immunohistochemical positive staining for the KI67 antigen after ERAS-801 treatment; Ie. Exploring the associations between the various biomarker evaluations (tissue and imaging), clinical outcome measures and adverse events. (Cohort A)
II. To evaluate the associations between exploratory biomarkers, clinical outcomes, and adverse events which include:
IIa. Estimating the efficacy of ERAS-801 at optimized dosing through PFS6, PFS, and OS as defined by mRANO/RANO 2.0; IIb. Exploring whether glycolytic index (GI) and pH-weighted CEST-SAGE-EPI contrast correlates with clinical responses; IIc. Exploring the associations between the various biomarker evaluations (tissue and imaging), clinical outcome measures and adverse events. (Cohort B)
III. To evaluate the associations between exploratory biomarkers, clinical outcomes, and adverse events which include:
IIIa. Estimating the efficacy of ERAS-801 through PFS, and OS as defined by mRANO/RANO 2.0; IIIb. Exploring whether glycolytic index (GI) and pH-weighted CEST-SAGE-EPI contrast correlates with clinical responses; IIIc. Exploring the associations between the various biomarker evaluations (tissue and imaging), clinical outcome measures and adverse events. (Cohort C)
OUTLINE: Patients are assigned to 1 of 3 cohorts.
COHORT A: Patients receive ERAS-801 orally (PO) once daily (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 echocardiography (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.
COHORT B: 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.
COHORT C: 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.
After completion of study treatment, patients are followed up at 30 days, then every 2 months up to documented disease progression, death, or the end of the study. Patients with disease progression are followed up every 3 months up to death, withdrawal of consent, or the end of the trial, whichever, occurs first.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's planned enrollment of 50 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Jonsson Comprehensive Cancer Center is the lead sponsor of 398 studies on the registry; 66 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
COHORT A:
Patients must have recovered from severe toxicity of prior therapy. The following intervals from previous treatments are required to be eligible:
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:
≥ 9.0 g/dL or ≥ 5.6 mmol/L
Creatinine ≤ 1 x (ULN) OR measured or calculated ≥ 30 mL/min for participant with creatinine levels > 1 x institutional ULN ( [GFR] can also be used in place of creatinine or creatinine clearance [CrCl])
COHORT B: Closed
COHORT C:
Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/La
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)
Exclusion Criteria:
COHORT A:
Participants with cardiovascular disease including, but not limited to:
COHORT B: Closed
COHORT C:
Participants with clinically significant cardiovascular disease including, but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Biospecimen Collection · Procedure: Echocardiography Test · Drug: EGFR Inhibitor ERAS-801 · Other: Fludeoxyglucose F-18 · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Procedure: Surgical Procedure
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.
Procedure: Biospecimen Collection · Procedure: Echocardiography Test · Drug: EGFR Inhibitor ERAS-801 · Other: Fludeoxyglucose F-18 · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography
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.
Procedure: Biospecimen Collection · Procedure: Echocardiography Test · Drug: EGFR Inhibitor ERAS-801 · Other: Fludeoxyglucose F-18 · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography
Undergo urine, blood, and CSF sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo ECHO
Also known as: EC, Echocardiography
Given PO
Also known as: ERAS 801, ERAS-801, ERAS801
Given FDG
Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Undergo brain MRI
Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Undergo FDG PET
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Undergo surgical resection
Also known as: Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery
Fludeoxyglucose F-18 (FDG) tumor uptake (Cohort A)
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.
Time frame: At baseline, prior to initiation of study treatment and after study treatment prior to surgery
Pharmacokinetics (PK) dose modification (Cohort B)
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.
Time frame: At day 1 and day 15
6 month progression free survival (Cohort C)
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.
Time frame: At 6 months
Incidence of adverse events
Adverse events will be described by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. Will be presented using a 95% confidence interval and 2-sided p-value, combined with Bayesian posterior means and High Posterior Density intervals. Descriptive summaries and data visualization will be used
Time frame: From enrollment to 30 days after the last dose of study treatment
Change in glycolytic index (GI)
The GI measurement will be measured by the product of FDG PET SUV and potential of hydrogen (pH)-weighted chemical exchange saturation transfer (CEST)-spin-and-gradient echo (SAGE)- echoplanar imaging (EPI) and will be compared to estimate the change in GI in the tumor area as a surrogate for changes in glycolytic flux.
Time frame: At baseline, prior to initiation of study treatment and after study treatment prior to surgery
pH-weighted CEST-SAGE-EPI
Amine proton CEST-SAGE-EPI will be evaluated for change in acidity in the tumor. Continued monitoring for tumor acidity will occur throughout the study treatment cycles.
Time frame: At baseline, prior to initiation of study treatment and after study treatment prior to surgery
PK profile
PK concentration data will be summarized using appropriate summary statistics and further details will be provided.
Time frame: At time of surgery and then at the beginning of each treatment cycle (1 cycle = 28 days)
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: ERAS-801
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