NCT07462377RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 5 Mar 2026
- Start date
- 31 Mar 2026
- Primary completion date
- Jul 2029
- Lead sponsor
- EpiBiologics
- Diseases
- Head and neck cancer, Lung cancer
- NCT number
- NCT07462377
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 110
- From 31 Mar 2026 to the primary completion date, Jul 2029
- 8 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Participant has history of uncontrolled illness.
Other
- Participant has symptomatic brain metastases.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH) Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| Site 104 - START New Jersey Coordinator of this site? Confirm its status | East Brunswick | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Site 107 - START New York - Long Island Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
| Site 105 - START Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Sarah Cannon and HCA Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Site 102 - START San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.