A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1) (NCT05222802) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
United States52 participantsStarted 2022-02-25
Plain-language summary
* 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 participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Limiting Toxicities (DLT)
Timeframe: Study Day 1 up to Day 29
2
Maximum Tolerated Dose (MTD)
Timeframe: Study Day 1 up to Day 29
3
Recommended Dose (RD)
Timeframe: Study Day 1 up to Day 29
4
Adverse Events
Timeframe: Assessed up to 24 months from time of first dose