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

May 5, 2026 updated by: EpiBiologics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • START Los Angeles
        • Contact:
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Astera Cancer Care
        • Contact:
    • New York
      • Lake Success, New York, United States, 11042
        • Not yet recruiting
        • START New York Long Island
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon and HCA Research Institute
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • South Texas Accelerated Research Therapeutics (START)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EPI-326
Experimental: Dose Escalation
Drug: EPI-326
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 3 years.
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).
Up to 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3 years.
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
Up to 3 years.
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
Up to 3 years.
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
Up to 3 years.
Objective response rate (ORR)
Time Frame: Up to 3 years.
Up to 3 years.
Duration of response (DOR)
Time Frame: Up to 3 years.
Up to 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EpiBiologics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPI-326-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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