A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC

Recruiting now · Phase 1

Conditions studied: Epidermal Growth Factor, Epidermal Growth Factor Receptor, Epidermal Growth Factor Receptor Gene Mutation, Non Small Cell, Non Small Cell Lung, Non Small Cell Lung Cancer, Head and Neck, Head and Neck Cancer, Head and Neck Cancers, Head and Neck Squamous Cell Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma HNSCC, NSCLC (Non-small Cell Lung Cancer), HNSCC, EGFR

In brief

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.

Key facts

Study ID

NCT07462377

Run by

EpiBiologics

People needed

110

Starts

2026-03-31

Expected to finish

2029-07-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Participant has history of uncontrolled illness.
• Participant has symptomatic brain metastases.
• 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 is running

• START Los Angeles — Los Angeles, California, United States (enrolling)
• Astera Cancer Care — East Brunswick, New Jersey, United States (enrolling)
• START New York Long Island — Lake Success, New York, United States (enrolling)
• Sarah Cannon and HCA Research Institute — Nashville, Tennessee, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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