Clinical trial 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 ERAS-801?
an investigational oral medicine being studied as a potential treatment for EGFR‑amplified or mutated glioblastoma is designed to block the EGFR protein on tumor cells, which may reduce their growth
Also referred to as ERAS 801, ERAS801.
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 study is testing whether ERAS-801 is safe and what side effects it causes in people with these brain tumors.
- Who it's for
- You may be able to join if you have an IDH‑wildtype, EGFR‑altered grade IV glioblastoma or gliosarcoma that can be removed or is growing again, especially if you are older.
- What's involved
- You would take ERAS-801, a medicine that blocks EGFR, and have regular doctor visits and tests to watch for safety.
- Time commitment
- The trial lasts several months and includes multiple visits for treatment and safety check‑ins.
- 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
- Patients must be 18 years of age or older on the day of signing informed consent
- Patients must have histologically proven surgically accessible World Health Organization (WHO) grade IV glioblastoma/gliosarcoma, which is...
- Patient tumor sample must have wild type IDH with evidence of EGFR mutation/amplification by Clinical Laboratory Improvement Act (CLIA)-certified...
- Patients may have had no more than two prior recurrences
- 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
- Participants may not be receiving any other investigational agents
- Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ERAS-801 are ineligible
- Participants with prior therapy with EGFR inhibitors such as EGFR kinase inhibitors or other EGFR-targeted agents that have the potential to deplete...
- Participants on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol.
- Participants must not have evidence of significant hematologic, renal, or hepatic dysfunction
- Participants must not have evidence of significant intracranial hemorrhage
See the full eligibility criteria
Who can join
- Patients must be 18 years of age or older on the day of signing informed consent
- Patients must have histologically proven surgically accessible World Health Organization (WHO) grade IV glioblastoma/gliosarcoma, which is progressive or recurrent following radiation therapy +/- chemotherapy
- Patient tumor sample must have wild type IDH with evidence of EGFR mutation/amplification by Clinical Laboratory Improvement Act (CLIA)-certified laboratory assay.
- Patients may have had no more than two prior recurrences
- 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.
- 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
- 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
- Paraffin embedded tissue must be available from initial surgical resection at diagnosis (prior to any treatment).
- 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)
- 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
- 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...
- Creatinine clearance (CrCl) should be calculated per institutional standard
- Total bilirubin ≤ 1.5 x ULN unless with Gilbert's syndrome
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x ULN
- 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...
- Patients must have left ventricular ejection fraction (LVEF) within normal institutional limits within 21 days of starting treatment
- Patients must have a 12-lead electrocardiogram performed within 2 weeks of treatment start with Fridericia's formula-corrected QT interval (QTcF) =\< 450 msec
- Patients must be able to provide written informed consent
- Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose
- 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.
- 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 must be ≥ 70 years of age at the time of informed consent, with a life expectancy \> 8 weeks
- Patients must have histologically proven newly diagnosed WHO grade 4 glioblastoma/gliosarcoma
- 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
- 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.
- 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)
- Absolute neutrophil count (ANC) ≥ 1000/uL
- Platelets ≥ 100000/uL
- 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
- 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
- Total bilirubin ≤ 1.5 x ULN unless with Gilbert's syndrome
- AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
- 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...
- 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...
- Patients must have left ventricular ejection fraction (LVEF) within normal institutional limits within 21 days of starting treatment
- Patients must have a 12-lead electrocardiogram performed within 2 weeks of treatment start with QTcF ≤ 450 msec
- Patients must be able to provide written informed consent
- 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...
- 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 must be able to swallow medication by mouth
What rules you out
- Participants may not be receiving any other investigational agents
- Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ERAS-801 are ineligible
- 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...
- 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.
- Participants must not have evidence of significant hematologic, renal, or hepatic dysfunction
- Participants must not have evidence of significant intracranial hemorrhage
- 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
- 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
- Pregnant women are excluded from this study because ERAS-801 has unknown potential for teratogenic or abortifacients effects.
- 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...
- 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...
- Patients with gastrointestinal conditions that may affect reliable administration/absorption of medications including difficulty swallowing/unable to swallow pills; malabsorption syndrome
- Participants receiving P-gp inhibitors are ineligible
- Participants may not have received previous radiation therapy to the brain
- Participants may not be receiving any other investigational agents
- Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ERAS-801 are ineligible
- 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.
- Participants must not have evidence of significant hematologic, renal, or hepatic dysfunction
- Participants must not have evidence of significant intracranial hemorrhage
- 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
- 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
- Sexually active male participants over the age of 70 with partners of childbearing potential unable or unwilling to use contraception
- 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...
- 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...
- Patients with gastrointestinal conditions that may affect reliable administration/absorption of medications including difficulty swallowing/unable to swallow pills; malabsorption syndrome
- Participants receiving P-gp inhibitors are ineligible
- Patients who have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial are ineligible
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, 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, but 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?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.