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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Participant has a life expectancy \> 12 weeks at Day 1. 2. Participant has an ECOG performance status of 0-2. 3. Participant has pathologically confirmed NSCLC or HNSCC. o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion. 4. Participant has locally advanced or metastatic NSCLC or HNSCC. 5. Participant has adequate organ function Exclusion Criteria: 1. Participant has history of uncontrolled illness. 2. Participant has symptomatic brain metastases. 3. 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.
About the study
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.
What is being tested
- EPI-326 (drug)
Sponsor: EpiBiologics · Participants: 110 · Started: Mar 31, 2026
Contact the study team
- EpiBiologics Clinical Trials · Phone: 650-955-7486
Official record on ClinicalTrials.gov — NCT07462377
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.