For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Willing and able to give written informed consent
  3. Diagnosis of Glioblastoma, IDH WT as defined by the WHO 2021 criteria
  4. Adequate organ function
  5. Willing to comply with all protocol-required visits, assessments, and procedures
  6. Able to swallow oral medication

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Prior treatment with an EGFR inhibitor for Glioblastoma
  2. Currently enrolled in another therapeutic study
  3. History of clinically significant cardiovascular disease
  4. Gastrointestinal conditions that may affect administration/absorption of oral medications
  5. Have an active infection (bacterial, fungal, or viral) requiring systemic therapy
  6. Pregnant or breastfeeding women
  7. 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
  8. Known allergies, hypersensitivity, or intolerance to ERAS-801 or its excipients
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Glioblastoma Multiforme

Age (in years)

18 - 99

Phase

Phase 1

Participants needed

90

Est. Completion Date

Sep 30, 2025

Treatment type

Interventional


Sponsor

Erasca, Inc.

ClinicalTrials.gov identifier

NCT05222802

Study number

ERAS-801-01

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