ERAS-801 for Glioblastoma

Recruiting at 7 trial locations

Overseen By Erasca Clinical Team

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Katmai Pharmaceuticals Inc.

Must not be taking: EGFR inhibitors

Disqualifiers: Cardiovascular disease, Active infection, others

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

Compensation: Varies

Number of Visits: Unknown

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ERAS-801, for individuals with glioblastoma, a type of brain cancer. The main goals are to determine the safety of ERAS-801, identify the optimal dose, and assess its effectiveness against cancer. Participants will either try different doses to find the right one or take the recommended dose if they have specific changes in a protein called EGFR. This trial targets those whose glioblastoma has returned after treatment and who have not used a similar drug before. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that ERAS-801 is generally well-tolerated by patients with recurrent glioblastoma multiforme (GBM), a type of brain cancer. Studies indicate it has a good safety record with manageable side effects. ERAS-801 effectively reaches the brain, which is crucial for treating conditions like GBM. Although more detailed safety information will emerge as trials progress, early results suggest it could be a safe option for those facing this challenging brain cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for glioblastoma, which often include surgery, radiation, and chemotherapy, ERAS-801 offers a novel approach by targeting EGFR alterations specifically. This drug is taken orally, which could make it more convenient for patients compared to traditional methods that may require hospital visits. Researchers are excited because ERAS-801 may provide a more targeted attack on cancer cells, potentially leading to better outcomes for those with recurrent glioblastoma.

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

Research has shown that ERAS-801 might help treat glioblastoma, a type of brain cancer. It blocks a protein called EGFR, which can stop the cancer from growing and spreading. In early animal studies, treatments targeting similar pathways killed many cancer cells and extended the animals' lives. Although still in early stages, initial results suggest that ERAS-801 might shrink tumors and extend patients' lives, especially those with certain genetic traits. The FDA recognized its promise by granting it fast track status, which speeds up its development. Participants in this trial will receive ERAS-801; some will undergo dose escalation to determine the optimal dose, while others will receive the recommended dose in the dose expansion phase. ^{1 4 6 7 8}

Who Is on the Research Team?

Les Brail

Principal Investigator

Medical Director

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My organs are working well.

Willing and able to give written informed consent

I can take pills by mouth.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

ERAS-801 is administered in sequential ascending doses to determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD)

4 weeks

Weekly visits for dose escalation monitoring

Dose Expansion

ERAS-801 is administered at the recommended dose to participants with EGFR alterations

24 months

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• ERAS-801

Trial Overview 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.

How Is the Trial Designed?

Group I: Dose Expansion (Part 2) Experimental Treatment 1 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 Treatment 1 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.

Who Is Running the Clinical Trial?

Katmai Pharmaceuticals Inc.

Lead Sponsor

Erasca, Inc.

Industry Sponsor

Trials

8

Recruited

1,200+

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. 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 ...

3. 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 ...

4. 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, ...

5. onclive.com onclive.com/view/fda-grants-fast-track-designation-to-eras-801-in-egfr-altered-glioblastoma

FDA Grants Fast Track Designation to ERAS-801 in EGFR ... The FDA has granted a fast track designation to ERAS-801 for the treatment of adult patients with glioblastoma harboring EGFR gene alterations.

6. academic.oup.com academic.oup.com/neuro-oncology/article/26/Supplement_8/viii107/7890521

CTNI-48. A PHASE 1 STUDY OF ERAS-801, A POTENT ... ERAS-801 shows well behaved PK with substantial CNS penetration, preliminary safety, and tolerability in patients with recurrent GBM. The ...

7. uclahealth.org uclahealth.org/clinical-trials/eras-801-treatment-resectable-and-progressive-or-recurrent

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

8. investors.erasca.com investors.erasca.com/news-releases/news-release-details/erasca-granted-fda-fast-track-designation-cns-penetrant-egfr

Erasca Granted FDA Fast Track Designation for CNS ... ERAS-801 has demonstrated broad preclinical activity against oncogenic EGFR variants and wildtype alterations.