A PHASE 1 STUDY TO EVALUATE THE CNS-PENETRANT EGFR/ERBB1 INHIBITOR ERAS-801 IN PATIENTS WITH RECURRENT GLIOBLASTOMA (THUNDERBOLT-1)
- 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.
- 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
- 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
- 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