A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)

Running, not enrolling · Phase 1

Conditions studied: Glioblastoma Multiforme

In brief

* To evaluate the safety and tolerability of escalating doses of ERAS-801 in study participants with recurrent glioblastoma multiforme (GBM). * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-801. * To evaluate the antitumor activity of ERAS-801. * To evaluate the PK profile of ERAS-801.

Key facts

Study ID

NCT05222802

Run by

Katmai Pharmaceuticals Inc.

People needed

52

Starts

2022-02-25

Expected to finish

2025-09-30

Last updated by the study team

2025-08-17

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Willing and able to give written informed consent
• Diagnosis of Glioblastoma, IDH WT as defined by the WHO 2021 criteria
• Adequate organ function
• Willing to comply with all protocol-required visits, assessments, and procedures
• Able to swallow oral medication

You may not qualify if…

• Prior treatment with an EGFR inhibitor for Glioblastoma
• Currently enrolled in another therapeutic study
• History of clinically significant cardiovascular disease
• Gastrointestinal conditions that may affect administration/absorption of oral medications
• Have an active infection (bacterial, fungal, or viral) requiring systemic therapy
• Pregnant or breastfeeding women
• Any serious underlying medical or psychiatric condition or evidence of any other significant clinical disorder or laboratory finding that renders the patient inappropriate to participate in the study
• Known allergies, hypersensitivity, or intolerance to ERAS-801 or its excipients

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• Miami Cancer Institute-Baptist Heath South Florida — Miami, Florida, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Sarah Cannon Research Institute (Tennessee Oncology) — Nashville, Tennessee, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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