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

NCT07462377 | Recruiting Phase 1 FDA Drug

• 1 other identifier: EPI-326-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

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

Keywords

Head and Neck Squamous Cell Carcinoma; HNSCC; Epidermal Growth Factor Receptor Gene Mutation; EGFR; Non Small Cell Lung Cancer; NSCLC

Outcome Measures

Primary Outcomes (2)

• Evaluation of the safety and tolerability of EPI-326

  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

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

  Up to 3 years.

Secondary Outcomes (6)

• Determination of maximum (Cmax) and minimum (Cmin) plasma concentration

  Up to 3 years.

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

  Up to 3 years.

• Determination of clearance (CL) from the blood

  Up to 3 years.

• Determination of volume of distribution (Vd)

  Up to 3 years.

• Objective response rate (ORR)

  Up to 3 years.

Study Arms (1)

EPI-326

EXPERIMENTAL

Experimental: Dose Escalation

Drug: EPI-326

Interventions

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.

Also known as: EPI-326 Injection

EPI-326

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• EpiBiologics: lead

Study Sites (6)

START Los Angeles

Los Angeles, California, 90025, United States

RECRUITING

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

RECRUITING

START New York Long Island

Lake Success, New York, 11042, United States

RECRUITING

Sarah Cannon and HCA Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

EpiBiologics Clinical Trials

CONTACT

650-955-7486; clinicaltrials@epibiologics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

US (6)