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.

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