NCT05222802Active, not recruitingPhase 1
A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
A Phase 1 Study to Evaluate the CNS-Penetrant EGFR/ERBB1 Inhibitor ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
Source: ClinicalTrials.gov · Last updated 17 Aug 2025
Brief summary (registry, in English)
* 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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 24 Jan 2022
- Start date
- 25 Feb 2022
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- Katmai Pharmaceuticals Inc.
- Diseases
- Glioblastoma
- NCT number
- NCT05222802
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 52
- From 25 Feb 2022 to the primary completion date, 31 Aug 2025
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Known allergies, hypersensitivity, or intolerance to ERAS-801 or its excipients
Lab values
- Prior treatment with an EGFR inhibitor for Glioblastoma
- 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
Other
- Currently enrolled in another therapeutic study
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Miami Cancer Institute-Baptist Heath South Florida Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Sarah Cannon Research Institute (Tennessee Oncology) Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.