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RECRUITING
NCT07462377
PHASE1

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

Sponsor: EpiBiologics

View on ClinicalTrials.gov

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.

Official title: A First-in-Human, Open-label, Multicenter, Phase 1 Study of EPI-326 in Patients With Epidermal Growth Factor Receptor-Mutant Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-03-31

Completion Date

2029-07

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

DRUG

EPI-326

EPI-326 is a tissue-selective bispecific antibody for EGFR-driven cancers. EPI-326 will be administered in the clinic via IV infusion.

Locations (6)

Site 105 - START Los Angeles

Los Angeles, California, United States

Site 104 - START New Jersey

East Brunswick, New Jersey, United States

Site 107 - START New York - Long Island

Lake Success, New York, United States

Sarah Cannon and HCA Research Institute

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Site 102 - START San Antonio

San Antonio, Texas, United States