RecruitingEpidermal Growth FactorEpidermal Growth Factor ReceptorEpidermal Growth Factor Receptor Gene Mutation
A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this 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.
Sponsor: EpiBiologics
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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.
Where it's recruiting
California
Los Angeles
New Jersey
East Brunswick
New York
Lake Success
Tennessee
Nashville
Texas
Houston · San Antonio
Source: ClinicalTrials.gov · NCT07462377 · last updated 2026-07-06