ERAS-801 for Glioblastoma

Recruiting at 7 trial locations

Overseen By Erasca Clinical Team

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Erasca, 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

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Les Brail

Principal Investigator

Medical Director

Eligibility Criteria

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

I am 18 years old or older.

My organs are working well.

Willing and able to give written informed consent

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

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

Treatment Details

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.

Participant Groups

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?

Erasca, Inc.

Lead Sponsor

Trials

8

Recruited

1,200+