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NCT Number: NCT07462377

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.

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Key information

Conditions

Epidermal Growth Factor Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell EGFR Epidermal Growth Factor Receptor Epidermal Growth Factor Receptor Gene Mutation HNSCC Head and Neck Head and Neck Cancer Head and Neck Cancers Head and Neck Neoplasms Head and Neck Squamous Cell Cancer Head and Neck Squamous Cell Carcinoma Head and Neck Squamous Cell Carcinoma HNSCC Lung Diseases Lung Neoplasms NSCLC (Non-small Cell Lung Cancer) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non Small Cell Non Small Cell Lung Non Small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

START Los Angeles, Los Angeles, California, United States

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About this study

This study will be a first-in-human (FIH), Phase 1, multicenter, open-label study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 as a single agent administered to patients with EGFR-mutant (per clinically validated molecular testing, e.g., next-generation sequencing [NGS]) locally advanced or metastatic NSCLC and locally advanced or metastatic HNSCC. All patients will be treated until documented disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

EPI-326

Drug

EPI-326 is a tissue-selective bispecific antibody for EGFR-driven cancers. EPI-326 will be administered in the clinic via IV infusion.

Other names: EPI-326 Injection

Primary outcomes

  1. Evaluation of the safety and tolerability of EPI-326

    Time frame: Up to 3 years.

    Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicity (DLTs).

  2. Determination of the recommended dose and schedule for EPI-326 administration

    Time frame: Up to 3 years.

    Maximum tolerated dose (MTD), maximum administered dose (MAD).

Secondary outcomes

  1. Determination of maximum (Cmax) and minimum (Cmin) plasma concentration

    Time frame: Up to 3 years.

    Drug concentration in the blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326.

  2. Determination of area under the concentration-time curve (AUC)

    Time frame: Up to 3 years.

    Drug concentration in blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326

  3. Determination of clearance (CL) from the blood

    Time frame: Up to 3 years.

    Drug concentration in blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326

  4. Determination of volume of distribution (Vd)

    Time frame: Up to 3 years.

    Drug concentration in blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326

  5. Objective response rate (ORR)

    Time frame: Up to 3 years.

  6. Duration of response (DOR)

    Time frame: Up to 3 years.

Study contacts

Contact information is provided by the study sponsor or research team.

EpiBiologics Clinical Trials

CONTACT

[email protected]

650-955-7486

Sponsors and collaborators

Lead sponsor

EpiBiologics

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 10, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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