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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

2026-04

Completion Date

2029-07

Last Updated

2026-03-25

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 (5)

START Los Angeles

Los Angeles, California, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

Sarah Cannon and HCA Research Institute

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States