This study is in progress, not accepting new patients

A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)

a study on Astrocytoma Glioblastoma Glioma

Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at Los Angeles 5368361, California 5332921 and other locations
Dates
study started
study ends around

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
    Los Angeles 5368361 California 5332921 90095 United States
  • Huntsman Cancer Institute
    Salt Lake City 5780993 Utah 5549030 84112 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Katmai Pharmaceuticals Inc.
ID
NCT05222802
Phase
Phase 1 research study
Study Type
Interventional
Participants
About 52 people participating
Last Updated