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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Diagnosis of Glioblastoma, IDH WT as defined by the WHO 2021 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 24 months from time of first dose
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a new drug, ERAS-801, for people with a certain type of brain tumor.
Who is the study for?
This trial is for adults over 18 with recurrent glioblastoma who can take pills orally and have good organ function. They must be able to consent to the study and follow its procedures. People with allergies to ERAS-801, past EGFR inhibitor treatments for glioblastoma, significant heart disease, active infections needing treatment, or gastrointestinal issues affecting drug absorption cannot join.Check my eligibility
What is being tested?
The trial tests different doses of a new medication called ERAS-801 in patients with recurrent glioblastoma to find the safest and most effective dose level. It also looks at how well it works against tumors and studies how the body processes the drug.See study design
What are the potential side effects?
Potential side effects of ERAS-801 are not specified but may include typical reactions related to oral medications targeting brain tumors such as headaches, nausea, fatigue, or other symptoms depending on individual tolerance.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My condition is Glioblastoma, IDH wild type.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed up to 24 months from time of first dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 24 months from time of first dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Dose Limiting Toxicities (DLT)
Maximum Tolerated Dose (MTD)
+1 moreSecondary outcome measures
Area under the curve
Duration of Response (DOR)
Half-life
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion (Part 2)Experimental Treatment1 Intervention
ERAS-801 will be orally administered at the recommended dose (as determined from Part 1) to study participants with recurrent GBM harboring alterations in EGFR.
Group II: Dose Escalation (Part 1)Experimental Treatment1 Intervention
ERAS-801 will be orally administered to study participants with recurrent GBM in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.
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Who is running the clinical trial?
Erasca, Inc.Lead Sponsor
7 Previous Clinical Trials
1,111 Total Patients Enrolled
Les BrailStudy DirectorMedical Director
Sachin Pai, M.D.Study DirectorMedical Director
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with an EGFR inhibitor for my brain cancer.I have stomach or intestine problems that could affect how I absorb pills.I am currently being treated for an infection.I am 18 years old or older.My organs are working well.I can take pills by mouth.My condition is Glioblastoma, IDH wild type.I have a history of serious heart problems.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation (Part 1)
- Group 2: Dose Expansion (Part 2)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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