ERAS-801 for Glioblastoma

(ERAS801-SARG Trial)

Overseen By Emese Filka

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: EGFR inhibitors, EIAEDs, P-gp inhibitors, others

Disqualifiers: Cardiovascular disease, Hepatic dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ERAS-801 for individuals with glioblastoma, a specific type of brain cancer. The research aims to determine if ERAS-801 is safe and can effectively slow down or shrink tumors with certain genetic features (EGFR mutation or amplification) that are worsening or recurring after treatment. Ideal candidates have glioblastoma that can be surgically removed and have experienced worsening conditions after initial treatments like radiation or chemotherapy. As a Phase 1 trial, this research focuses on understanding how ERAS-801 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications before participating. Specifically, you must not be on enzyme-inducing anti-epileptic drugs and should avoid drugs, food, or supplements that affect certain liver enzymes (CYP3A4, CYP2C8, CYP2D6) and P-glycoprotein within 10 days of starting the trial. If you're on these, you'll need to stop them before joining.

Is there any evidence suggesting that ERAS-801 is likely to be safe for humans?

Research has shown that ERAS-801, the treatment being tested, has been administered to patients with recurrent glioblastoma, a type of brain cancer, in previous studies. In one study, 33 patients received ERAS-801, and it was generally well-tolerated. This treatment blocks a protein that can help stop cancer cells from growing. The FDA has granted it special status, indicating promise for treating brain tumors. While safety evaluations continue, current evidence suggests that patients can take ERAS-801 safely, though more data is needed to fully understand any potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for glioblastoma, such as surgery, radiation, and chemotherapy, ERAS-801 is unique because it targets a specific pathway involved in cancer cell growth. Researchers are excited about ERAS-801 because it can be taken orally and has the potential to penetrate the blood-brain barrier more effectively than other treatments. This could mean better delivery of the drug to the brain tumor, potentially leading to more effective treatment outcomes with fewer side effects.

What evidence suggests that ERAS-801 might be an effective treatment for glioblastoma?

Research has shown that ERAS-801 targets a protein called EGFR, often found in high amounts on glioblastoma cells. This protein causes excessive cell multiplication. By blocking EGFR, ERAS-801 might help slow or shrink tumors. In studies with patients who have recurring glioblastoma, ERAS-801 showed promise in stopping tumor growth. Participants in this trial will receive ERAS-801, designed to effectively reach and act on brain tumors, offering hope for those with this aggressive cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Phioanh Nghiemphu, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with a specific brain cancer called IDH wildtype grade IV glioblastoma or astrocytoma that has high levels of EGFR and can be surgically removed. It's aimed at those whose tumors are growing, spreading, or have returned after treatment.

Inclusion Criteria

My condition has recurred no more than twice.

Women of childbearing potential must have a negative pregnancy test and agree to contraception measures

I am mostly able to care for myself but may need occasional help.

Exclusion Criteria

Patients with known psychiatric or substance abuse disorders are ineligible

I do not have any uncontrolled illnesses.

I do not have liver or bile duct diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Treatment

Participants receive ERAS-801 orally once daily for 8-14 days prior to undergoing scheduled surgical resection

1-2 weeks

Daily visits for drug administration

Surgery

Participants undergo scheduled surgical resection

1 day

1 visit (in-person)

Post-surgery Treatment

Participants receive ERAS-801 orally once daily on days 1-28 of each cycle, with cycles repeating every 28 days

28 days per cycle

Monthly visits for monitoring and drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-ups at 30 days, then every 2 months up to documented disease progression, death, or end of study

Up to end of study

Regular follow-up visits every 2 months

What Are the Treatments Tested in This Trial?

Interventions

• ERAS-801

Trial Overview The trial tests ERAS-801, an EGFR inhibitor designed to enter the central nervous system and target tumor cells with excessive EGFR. The study includes surgery, imaging tests like MRI and PET scans, biospecimen collection, and heart monitoring through echocardiography.

How Is the Trial Designed?

Group I: Treatment (ERAS-801) Experimental Treatment 7 Interventions

Patients receive ERAS-801 PO QD for 8-14 days prior to undergoing scheduled surgical resection. Starting no more than 28 days after surgery, patients then receive ERAS-801 PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO, urine and blood sample collection and brain MRI throughout the study. Additionally, patients undergo CSF sample collection at the time of surgery and FDG PET on study.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07089641

NCT07089641 | ERAS-801 for the Treatment of Resectable ... This phase Ib trial tests the safety and side effects of ERAS-801 in treating patients with isocitrate dehydrogenase (IDH) wildtype, epidermal growth factor ...

2. investors.erasca.com investors.erasca.com/news-releases/news-release-details/erasca-achieves-key-milestones-naporafenib-and-eras-801-programs

Erasca Achieves Key Milestones for Naporafenib and ... Thirty-three patients with recurrent glioblastoma (rGBM) were enrolled in seven dose escalation cohorts. ERAS-801 monotherapy has been granted ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05222802

NCT05222802 | A Study to Evaluate ERAS-801 in Patients ... ERAS-801 will be orally administered to study participants with recurrent GBM in sequential ascending doses until unacceptable toxicity, disease progression, ...

4. braintumor.org braintumor.org/news/turning-resistance-into-vulnerability-nbts-funded-discovery-drives-new-glioblastoma-clinical-trial%EF%BF%BC/

NBTS-Funded Discovery Drives New Glioblastoma Clinical ... In preclinical models, ABBV-155 caused dramatic tumor cell death, shrank tumors, and improved survival — especially when paired with radiation ...

5. cancer.gov cancer.gov/clinicaltrials/NCI-2025-03083

Study of ABBV-637 or ABBV-155 With ERAS-801 for ... By blocking the EGFR protein, ERAS-801 may stop the growth and spread of tumor cells. Giving ABBV-637 or ABBV-155 in combination with ERAS-801 may be safe, ...

6. cancernetwork.com cancernetwork.com/view/eras-801-receives-odd-from-fda-for-malignant-glioma-glioblastoma

ERAS-801 Receives ODD From FDA for Malignant Glioma ... Orally bioavailable, small molecule EGFR inhibitor ERAS-801 has received FDA orphan drug designation for malignant glioma including glioblastoma.

7. trialx.com trialx.com/clinical-trials/listings/309152/eras-801-for-the-treatment-of-resectable-and-progressive-or-recurrent-idh-wildtype-grade-iv-glioblastoma-or-astrocytoma-with-an-egfr-amplification-or-mutation-eras801-sarg-trial/

ERAS-801 for the Treatment of Resectable and ... Overview. This phase Ib trial tests the safety and side effects of ERAS-801 in treating patients with isocitrate dehydrogenase (IDH) ...