A Phase Ib Open Label Clinical Trial to Evaluate the Safety and Efficacy of ERAS-801 in Surgically Accessible Recurrent Glioblastoma Patients With EGFR Amplification or Mutation (ERAS801-SARG)
Jonsson Comprehensive Cancer Center
Summary
This phase Ib trial tests the safety and side effects of ERAS-801 in treating patients with isocitrate dehydrogenase (IDH) wildtype, epidermal growth factor receptor (EGFR) amplified or mutated grade IV glioblastoma or astrocytoma that can be removed by surgery (resectable) and that is growing, spreading, or getting worse (progressive) or that has come back after a period of improvement (recurrent). Glioblastoma is the most common brain cancer in adults and survival rates remain poor despite treatment including surgery, radiation and chemotherapy. EGFR is a protein found on the surface of some cells, to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of tumor cells, so these cells may divide excessively in the presence of epidermal growth factor. ERAS-801, an EGFR inhibitor that can penetrate the central nervous system, binds to the tumor cells that express EGFR and may help shrink or slow the growth of the tumor cells.
Description
PRIMARY OBJECTIVES: I. To evaluate the glucose utilization in the tumor from the glioblastoma patients treated with EGFR inhibitor ERAS-801 (ERAS-801). II. To evaluate the influence of ERAS-801 treatment on the apoptotic machinery in recurrent glioblastoma. III. To evaluate the safety and tolerability of ERAS-801 recommended phase 2 dose (RP2D) in recurrent glioblastoma. SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetic (PK) profile in plasma, cerebrospinal fluid (CSF), and tumor tissue of ERAS-801 in recurrent glioblastomas. II. To evaluate the pharmacodynamic (PD) impact of ERAS…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must be 18 years of age or older on the day of signing informed consent * Patients must have histologically proven surgically accessible World Health Organization (WHO) grade IV glioblastoma/astrocytoma, which is progressive or recurrent following radiation therapy +/- chemotherapy * Patient tumor sample must have wild type IDH with evidence of EGFR mutation/amplification by Clinical Laboratory Improvement Act (CLIA)-certified laboratory assay * Patients may have had no more than two prior recurrences * Patient must be able to tolerate MRIs. Pre-study enrollment…
Interventions
- ProcedureBiospecimen Collection
Undergo urine, blood, and CSF sample collection
- ProcedureEchocardiography Test
Undergo ECHO
- DrugEGFR Inhibitor ERAS-801
Given PO
- OtherFludeoxyglucose F-18
Given FDG
- ProcedureMagnetic Resonance Imaging
Undergo brain MRI
- ProcedurePositron Emission Tomography
Undergo FDG PET
- ProcedureSurgical Procedure
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California