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

NCT07462377 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • EpiBiologics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-07-31
Completion
2029-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07462377 on ClinicalTrials.gov