Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 1 Study to Evaluate the CNS-Penetrant EGFR/ERBB1 Inhibitor ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)

Details

This is a Phase 1, open-label, multicenter clinical study evaluating ERAS-801 as a monotherapy. The study will initially commence with dose escalation of ERAS-801 in study participants with recurrent GBM. Once the MTD and/or RD has been determined from dose escalation, then dose expansion of ERAS-801 may commence in study participants with recurrent GBM harboring alterations in epidermal growth factor receptor (EGFR).

Keywords

Glioblastoma Multiforme, GBM, EGFR, epidermal growth factor receptor, alteration, ERBB1, Glioblastoma, ERAS-801

Eligibility

You can join if…

Open to people ages 18-99

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Huntsman Cancer Institute accepting new patients
    Salt Lake City Utah 84112 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Erasca, Inc.
ID
NCT05222802
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated