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A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
Sponsor: EpiBiologics
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
Conditions
Interventions
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