Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
Lead Sponsor:
Katmai Pharmaceuticals Inc.
Collaborating Sponsors:
Erasca, Inc.
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
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 Rec...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05222802
Start Date
February 25 2022
End Date
September 30 2025
Last Update
August 17 2025
Active Locations (8)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
Miami Cancer Institute-Baptist Heath South Florida
Miami, Florida, United States, 33176
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
Henry Ford Health System
Detroit, Michigan, United States, 48202