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
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
99 Years

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

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
22-000189
Category
Neurology
Oncology
Contact
Emese Filka
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05222802
For detailed technical eligibility, visit ClinicalTrials.gov.