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RecruitingPhase 1NCT07462377
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedEPI-326

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 14, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?EpiBiologics

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
EpiBiologics
Interventions being studied
Drug: EPI-326
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→Metastatic or stage IV→
Biomarkers
EGFR→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Participant has a life expectancy \> 12 weeks at Day 1. 2. Participant has an ECOG performance status of 0-2. 3. Participant has pathologically confirmed NSCLC or HNSCC. o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion. 4. Participant has locally advanced or metastatic NSCLC or HNSCC. 5. Participant has adequate organ function

Reasons someone may not be able to joinExclusion criteria

1. Participant has history of uncontrolled illness. 2. Participant has symptomatic brain metastases. 3. Participant has a diagnosis of any secondary malignancy within 3 years prior to enrollment, except for those patients treated with curative intent and no evidence of active disease.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Site 105 - START Los AngelesLos Angeles, California
  • Site 104 - START New JerseyEast Brunswick, New Jersey
  • Site 107 - START New York - Long IslandLake Success, New York
  • Sarah Cannon and HCA Research InstituteNashville, Tennessee
  • MD Anderson Cancer CenterHouston, Texas
  • Site 102 - START San AntonioSan Antonio, Texas
  • Samsung Medical CenterSeoul
  • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)Kaohsiung City

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 14, 2026. Always confirm current availability with the study team.

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