Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07462377

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

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

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
110 (estimated)
Sponsor
EpiBiologics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

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

Timeline

Start date
2026-04-01
Primary completion
2029-07-01
Completion
2029-07-01
First posted
2026-03-10
Last updated
2026-03-25

Locations

5 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07462377. Inclusion in this directory is not an endorsement.