Additional eligibility criteria include having adequate organ function a willingness to comply with all protocol-required visits, assessments, and procedures and being able to swallow oral medication. Patients 18 years and older with a diagnosis of isocitrate dehydrogenase wild-type glioblastoma based on World Health Organization 2021 criteria are eligible for enrollment on the trial. Secondary end points include the plasma concentration and half-life of ERAS-801, objective response rate, duration of response, and time to response.
FASTTRACK SCHEDULE VERSION 3 FOR SALE TRIAL
The primary end points of the THUNDERBOLT-1 trial include determining dose-limiting toxicities, the maximum tolerated dose, the recommended dose, and adverse effects. Investigators will orally administer ERAS-801 to patients in sequential ascending doses until unacceptable toxicity or progressive disease as part of a dose escalation portion, which will determine the recommended dose for the dose expansion portion to further assess the agent.
Investigators of the open-label, multi-center phase 1 THUNDERBOLT-1 trial are assessing the tolerability, safety, and preliminary efficacy of ERAS-801 monotherapy in patients with recurrent glioblastoma. Across patient-derived glioblastoma models, ERAS-801 yielded a survival benefit in 93% of EGFR mutant and/or amplified models while showing statistically significant improvements in brain penetrance and prolonged survival compared with other approved EGFR tyrosine kinase inhibitors like osimertinib (Tagrisso), lapatinib (Tykerb), and erlotinib (Tarceva). The orally available, selective, highly potent small molecule EGFR inhibitor ERAS-801 was designed to exhibit significantly enhanced central nervous system penetration. “We look forward to working closely with the FDA to expedite clinical development of ERAS-801 for these patients and anticipate reporting initial monotherapy data from the phase 1 THUNDERBBOLT-1 trial in recurrent in the second half of 2023.” Lim, MD, chairman, chief executive officer, and co-founder of Erasca, said in the press release. “Receiving from the FDA underscores the serious unmet medical need in patients with and reinforces the promise that ERAS-801 may offer as a differentiated treatment option,” Jonathan E. Investigators anticipate a readout of phase 1 trial data in the second half of 2023. 2 Clearance of the application permitted investigators to continue with their evaluation of single-agent ERAS-801 in patients with recurrent glioblastoma as part of the phase 1 THUNDERBOLT-1 trial (NCT05222802). The FDA originally cleared an investigational new drug application for ERAS-801 in this patient population in December 2021.
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