RecruitingPhase 1NCT07462377

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

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

Sponsor

EpiBiologics

Enrollment

110 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Head and Neck Head and Neck Squamous Cell Carcinoma (HNSCC)Head and Neck Cancer Non-small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma HNSCC NSCLC (Non-small Cell Lung Cancer)Head and Neck Squamous Cell Cancer Head and Neck Cancers Non-Small-Cell Lung EGFR Epidermal Growth Factor Receptor Epidermal Growth Factor Receptor Gene Mutation Epidermal Growth Factor Non Small Cell

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called EPI-326 for people with egfr, epidermal growth factor, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEPI-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)

START Los Angeles

Los Angeles, California, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

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

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07462377

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