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Virus Therapy

ERAS-801 for Glioblastoma

Phase 1
Waitlist Available
Research Sponsored by Erasca, Inc.
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 below
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I am 18 years old or older.
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My condition is Glioblastoma, IDH wild type.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 24 months from time of first dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 24 months from time of first dose for reporting.

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 more
Secondary outcome measures
Area under the curve
Duration of Response (DOR)
Half-life
+4 more

Trial 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.

Find a Location

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

ERAS-801 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05222802 — Phase 1
Glioblastoma Research Study Groups: Dose Escalation (Part 1), Dose Expansion (Part 2)
Glioblastoma Clinical Trial 2023: ERAS-801 Highlights & Side Effects. Trial Name: NCT05222802 — Phase 1
ERAS-801 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05222802 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation enrolling participants at present?

"The clinical trial is enlisting patients, as chronicled on clinicaltrials.gov. It was initially publicized on February 25th 2022 and the most recent update to its listing occurred November 14th 2022."

Answered by AI

Are there various sites hosting this medical experiment in the state?

"This medical research is being conducted at multiple different sites throughout the United States, including major cities such as New york and Los Angeles. For instance, Memorial Sloan Kettering Cancer Center in NY, University of California-Los Angeles in LA, and Miami Cancer Institute - Baptist Health South Florida are all hosting trials for this project. Additionally there are 7 other locations across America that are running clinical studies related to this trial."

Answered by AI

What is the stated objective of this trial?

"This trial seeks to evaluate Dose Limiting Toxicities (DLT) over a 29 day period as its primary outcome. Subsequent objectives include gauging Plasma concentration, the amount of time required for it's peak absorption rate, and calculating ERAS-801's half life."

Answered by AI

What criteria must one meet to be eligible for this research endeavor?

"This medical trial seeks 90 individuals aged between 18 and 99 who are diagnosed with glioblastoma. Furthermore, applicants must be able to provide informed consent, meet WHO 2021 criteria for IDH WT status, possess sufficient organ function, agree to adhere to protocol-mandated visits/assessments/procedures, and demonstrate the ability to ingest oral medication in order to qualify."

Answered by AI

Could you outline the potential harms associated with ERAS-801 for patients?

"Due to the limited evidence supporting efficacy and safety, ERAS-801 received a score of 1."

Answered by AI

What is the current size of the cohort participating in this trial?

"This clinical trial requires the participation of 90 eligible test subjects. Those interested can apply at locations such as Memorial Sloan Kettering Cancer Center in New york, and University of California, Los Angeles in LA."

Answered by AI

Does the trial accept geriatric patients?

"This research is seeking participants of legal age, with the range being from 18 to 99. Separately, there are 35 trials for minors and 416 studies suitable for individuals over 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
2022. "A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05222802.
All > Glioblastoma New York
~12 spots leftby Jan 2025
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