A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
NCT07462377
This study is recruiting at 6 US sites in 5 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Epidermal Growth Factor
- Epidermal Growth Factor Receptor
- Epidermal Growth Factor Receptor Gene Mutation
- Non Small Cell
- Non Small Cell Lung
- Non Small Cell Lung Cancer
- Head and Neck
- Head and Neck Cancer
- Head and Neck Cancers
- Head and Neck Squamous Cell Cancer
- Head and Neck Squamous Cell Carcinoma
- Head and Neck Squamous Cell Carcinoma HNSCC
- NSCLC (Non-small Cell Lung Cancer)
- HNSCC
- EGFR
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- EpiBiologics
- Last updated on ClinicalTrials.gov
- October 14, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 1
- Site 105 - START Los Angeles · Los Angeles, CA
New Jersey · 1
- Site 104 - START New Jersey · East Brunswick, NJ
New York · 1
- Site 107 - START New York - Long Island · Lake Success, NY
Tennessee · 1
- Sarah Cannon and HCA Research Institute · Nashville, TN
Texas · 2
- MD Anderson Cancer Center · Houston, TX
- Site 102 - START San Antonio · San Antonio, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.