EGFR Inhibitor ERAS-801

PRIMARY OBJECTIVE: I. To evaluate the glucose utilization in the tumor from the glioblastoma patients treated with EGFR inhibitor ERAS-801 (ERAS-801). (Cohort A) II. To evaluate the changes in maximum concentration (Cmax) at dose optimized ERAS-801 correlating with corrected QT interval (QTc) prolongation. (Cohort B) III.

To evaluate the tolerability and efficacy of ERAS-801 recommended phase 2 dose (RP2D) in patients ≥ 70 years of age with newly diagnosed glioblastoma. (Cohort C) IV. To evaluate the 6 month progression free survival (PFS6) and response rate (RR) of ERAS-801 in patients ≥ 70 years of age with newly diagnosed glioblastoma. (Cohort C) SECONDARY OBJECTIVES: I.

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.

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 gliosarcoma that can be removed by surgery (resectable) and that is growing, spreading, or getting worse (progressive), that has come back after a period of improvement (recurrent) or that is newly diagnosed in an elderly patient.

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.

Registro actualizado en ClinicalTrials.gov →

• COHORT A: Patients must be 18 years of age or older on the day of signing informed consent
• COHORT A: Patients must have histologically proven surgically accessible World Health Organization (WHO) grade IV glioblastoma/gliosarcoma, which is progressive or recurrent following radiation therapy +/- chemotherapy
• COHORT A: Patient tumor sample must have wild type IDH with evidence of EGFR mutation/amplification by Clinical Laboratory Improvement Act (CLIA)-certified laboratory assay. Patients with EGFR mutations in T790M or exon 20 will be excluded
• COHORT A: Patients may have had no more than two prior recurrences
• COHORT A: Patient must be able to tolerate MRIs. Pre-study enrollment MRIs must be available for central review, including at least the immediate pre-progression scan and the scan demonstrating progression. Patients must have measurable, by RANO, supratentorial contrast-enhancing progressive or recurrent high-grade glioma by MRI imaging within 28 days prior to enrollment

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.