Phase 1 Trial Evaluating EPI-326 by IV Infusion in Patients with EGFR-Mutant Non-Small Cell Lung Cancer or Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, pharmacodynamics PD, and preliminary anti-tumor activity of increasing doses of EPI-326 in patients with locally advanced or metastatic head and neck squamous cell carcinoma HNSCC and those with EGFR-mutant locally advanced or metastatic non-small cell lung cancer NSCLC. This first-in-human, phase 1 multicenter, open-label study aims to determine appropriate dosing and assess initial effects of EPI-326 in these patients. EPI-326 is a tissue-selective bispecific antibody targeting EGFR-driven cancers and is administered by intravenous infusion in the clinic. Patients will receive escalating doses of EPI-326 as a single agent until they experience disease progression, unacceptable side effects, choose to withdraw, or the study ends. This study includes a dose escalation period to identify the recommended dose and schedule for administration. Participants will be monitored for safety and tolerability, with assessments including blood tests to measure drug concentration over time, clearance, and distribution. Researchers will also evaluate tumor response and duration of response over a period of up to three years. The study involves continuous treatment and follow-up visits to observe effects and manage any adverse events during the trial period.

A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC