Clinical Trial

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

Recruiting Phase 1
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Summary
A phase 1 study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 administered to patients with locally advanced or metastatic HNSCC and to patients with any documented EGFR-mutant locally advanced or metastatic NSCLC.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2026-03-05; most recent amendment 2026-07-01.
Status change: Not Yet Recruiting → Recruiting 2026-03-23
Trial Details
NCT Number NCT07462377
Lead Sponsor EpiBiologics
Conditions Epidermal Growth Factor, Epidermal Growth Factor Receptor, Epidermal Growth Factor Receptor Gene Mutation, Non Small Cell, Non Small Cell Lung, Non Small Cell Lung Cancer, Head and Neck, Head and Neck Cancer +7 more
Enrollment 110 participants
Start Date 2026-03-31
Primary Completion 2029-07 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-06