Open
Actively Recruiting
A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
Join this Trial
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Study Stats
Protocol No.
22-000189
Category
Brain Cancer
Principal Investigator
Contact
Location
- UCLA Westwood