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New treatment option for Glioblastoma
Official title 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
ClinicalTrials.gov ID: NCT07089641
What this study is testing
What is EGFR Inhibitor ERAS-801?
EGFR Inhibitor ERAS-801 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for glioblastoma.
Also referred to as ERAS 801, ERAS-801.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- COHORT A: Patient tumor sample must have wild type IDH with evidence of EGFR mutation/amplification by Clinical Laboratory Improvement Act...
- 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...
You likely can't join if
- 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...
- COHORT A: Participants with prior therapy with EGFR inhibitors such as EGFR kinase inhibitors or other EGFR-targeted agents that have the potential...
- COHORT A: Participants on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol. Patients may be on non-enzyme...
- 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 \ 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...
- 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...
- 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...
- 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...
- 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 \ 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...
- 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...
- 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...
- 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...
- COHORT C: Patients must be able to swallow medication by mouth
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.