RecruitingInterventionalPhase 1

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

NCT ID: NCT07462377Sponsor: EpiBiologicsLast updated: 2026-06-10

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.

Arms & interventions

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

Outcome measures

Primary

Evaluation of the safety and tolerability of EPI-326
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicity (DLTs).
Time frame: Up to 3 years.
Determination of the recommended dose and schedule for EPI-326 administration
Maximum tolerated dose (MTD), maximum administered dose (MAD).
Time frame: Up to 3 years.

Secondary

Determination of maximum (Cmax) and minimum (Cmin) plasma concentration
Time frame: Up to 3 years.
Determination of area under the concentration-time curve (AUC)
Time frame: Up to 3 years.
Determination of clearance (CL) from the blood
Time frame: Up to 3 years.
Determination of volume of distribution (Vd)
Time frame: Up to 3 years.
Objective response rate (ORR)
Time frame: Up to 3 years.
Duration of response (DOR)
Time frame: Up to 3 years.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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.