A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
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.
Checked against the public recordLast updated Jul 6, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- EpiBiologics
- Interventions being studied
- Drug: EPI-326
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- START Los AngelesLos Angeles, California
- Astera Cancer CareEast Brunswick, New Jersey
- START New York Long IslandLake Success, New York
- Sarah Cannon and HCA Research InstituteNashville, Tennessee
- MD Anderson Cancer CenterHouston, Texas
- South Texas Accelerated Research Therapeutics (START)San Antonio, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 6, 2026. Always confirm current availability with the study team.