A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- 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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Glioblastoma Multiforme
Age (in years)
18 - 99
Phase
Phase 1
Participants needed
90
Est. Completion Date
Sep 30, 2025
Treatment type
Interventional
Sponsor
Erasca, Inc.
ClinicalTrials.gov identifier
NCT05222802
Study number
ERAS-801-01
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