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New antibody EPI-326 enters first human trials for tough cancers

NCT ID NCT07462377

Recruiting now Disease control Sponsor: EpiBiologics Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tests a new drug called EPI-326 in about 110 people with advanced lung or head & neck cancers that have specific EGFR mutations. The drug is a bispecific antibody designed to target cancer cells more precisely. The main goals are to check safety, find the right dose, and see early signs of tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

EPI-326 (a bispecific antibody given by IV infusion)

What this could lead to

If it works, this could point toward a new treatment option for certain lung and head & neck cancers that have not responded to other therapies.

What could go wrong

This is a very early Phase 1 trial with only 110 people, focused on safety and dosing. It may not show strong anti-tumor effects, and side effects are unknown.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma non-small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

EGFR EPIDERMAL GROWTH FACTOR EPIDERMAL GROWTH FACTOR RECEPTOR EPIDERMAL GROWTH FACTOR RECEPTOR GENE MUTATION 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) HNSCC NON SMALL CELL NON SMALL CELL LUNG NON-SMALL-CELL LUNG CANCER NSCLC (NON-SMALL CELL LUNG CANCER)

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Astera Cancer Care

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • MD Anderson Cancer Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • START Los Angeles

    RECRUITING

    Los Angeles, California, 90025, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • START New York Long Island

    RECRUITING

    Lake Success, New York, 11042, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Sarah Cannon and HCA Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • South Texas Accelerated Research Therapeutics (START)

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••