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.
Key facts
- Who runs it
- EpiBiologics
- Where
- Kaohsiung City, TaiwanSee the siteAlso in 2 other countries, 7 sites
- Trial code
- Registry title
- A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 110 people, planned
- Started
- 31 Mar 2026
- Expected to end
- Jul 2029
- Type of study
- Interventional
- Treatments tested
- EPI-326
- Record updated
- 14 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR mutation, or with head and neck squamous cell cancer (HNSCC). It tests the new drug EPI-326.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- Locally advanced or metastatic NSCLC or HNSCC, confirmed by tissue examination. Life expectancy over 12 weeks and ECOG performance status of 0-2.
- Biomarker or test result
- For lung cancer (NSCLC): the tumor has any documented EGFR mutation, insertion, or deletion.
Main reasons for not taking part
- History of uncontrolled illness
- Brain metastases that cause symptoms
- Another cancer diagnosed within the last 3 years, unless it was treated with the aim of removing it completely and no active disease remains
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Taiwan
Also in 2 other countries, 7 sites
- Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)Kaohsiung City, TaiwanContact: Hui-Ching WangTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- EPI-326Treatment being tested
Experimental: Dose Escalation
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- EPI-326 for lung and head and neck cancers with EGFR changesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 14 October 2026