What side effects are associated with this type of intervention?

Common treatments for glioblastoma, including chemotherapy, radiation therapy, and investigational antitumor agents like ERAS-801, often result in side effects such as fatigue, nausea, vomiting, hair loss, and myelosuppression. Specific to investigational antitumor agents, patients may experience headache, scalp pain, and feeling cold. Each treatment may also have unique side effects based on its specific mechanism of action.

What prior FDA approvals exist?

The FDA has approved several antitumor agents for the treatment of Glioblastoma. Temozolomide, an oral alkylating agent, is one of the most commonly used drugs, approved for use in combination with radiotherapy and as maintenance therapy. Bevacizumab, a monoclonal antibody targeting VEGF, has also been approved for recurrent Glioblastoma. These treatments focus on inhibiting tumor growth and improving survival rates, similar to the investigational agent ERAS-801, which is being studied for its safety, tolerability, and antitumor activity in recurrent Glioblastoma.

What other types of research exist?

Promising novel alternatives to ERAS-801 for glioblastoma patients include: 1) Ivosidenib, a mutant-IDH1 inhibitor, which has shown tolerability and potential efficacy in IDH1-mutant gliomas. 2) Vorasidenib, a dual mutant-IDH1/2 inhibitor, currently in phase III trials for IDH1/2-mutant gliomas. 3) Bevacizumab, an angiogenesis inhibitor, which has been evaluated for its efficacy in glioblastoma. 4) Immunotherapies such as PD-1 blockade with nivolumab, which has shown activity in recurrent high-grade gliomas. These alternatives represent the forefront of glioblastoma treatment research and may offer new hope for patients.

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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

Must not have

Have an active infection (bacterial, fungal, or viral) requiring systemic therapy

Prior treatment with an EGFR inhibitor for Glioblastoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed up to 24 months from time of first dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ERAS-801, a new drug for treating brain cancer. It focuses on patients whose brain cancer has returned after treatment. The drug works by blocking signals that help cancer cells grow. Researchers want to find the safest and most effective dose of ERAS-801. ERAs may be useful for treating cancer patients.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for an infection.

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I have been treated with an EGFR inhibitor for my brain cancer.

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I have a history of serious heart problems.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Dose Limiting Toxicities (DLT)

Maximum Tolerated Dose (MTD)

+1 more

Secondary study objectives

Area under the curve

Duration of Response (DOR)

Half-life

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Glioblastoma treatments typically include surgery, radiation therapy, and chemotherapy. Surgery aims to remove as much of the tumor as possible. Radiation therapy uses high-energy beams to kill cancer cells and shrink tumors. Chemotherapy, including agents like temozolomide, works by damaging the DNA of cancer cells, preventing them from dividing and growing. ERAS-801, an antitumor agent under investigation, likely targets specific pathways involved in tumor growth and survival. Understanding these mechanisms is crucial for Glioblastoma patients as it helps in selecting the most effective treatment plan, potentially improving outcomes and managing side effects.