EPI-326 for lung and head and neck cancers with EGFR changes
Tests EPI-326 in adults with advanced EGFR-mutant lung cancer or head and neck cancer.
Plain-language title generated from the registry record
Registry title: A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
Key facts
- Where
- Kaohsiung City, TaiwanSee the site
- Phase
- Phase 1
Where in Taiwan
- Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)Kaohsiung City, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- EpiBiologics
- Trial code
- NCT07462377
- Record updated
- 14 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Participant has a life expectancy > 12 weeks at Day 1; Participant has an ECOG performance status of 0-2; Participant has pathologically confirmed NSCLC or HNSCC; o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion; Participant has locally advanced or metastatic NSCLC or HNSCC; Participant has adequate organ function.
Exclusion: Participant has a diagnosis of any secondary malignancy within 3 years prior to enrollment, except for those patients treated with curative intent and no evidence of active disease; Participant has history of uncontrolled illness; Participant has symptomatic brain metastases.