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Recruiting NCT07462377

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

Phase I Interventional Epidermal Growth Factor Epidermal Growth Factor Receptor Epidermal Growth Factor Receptor Gene Mutation Non Small Cell

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EPI-326.
Who it may be relevant to
Registry conditions: Epidermal Growth Factor, Epidermal Growth Factor Receptor, Epidermal Growth Factor Receptor Gene Mutation, Non Small Cell. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • Evaluation of the safety and tolerability of EPI-326 [Time frame: Up to 3 years.]
  • Determination of the recommended dose and schedule for EPI-326 administration [Time frame: Up to 3 years.]
Secondary outcome measures (6)
  • 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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • START Los Angeles — Los Angeles
  • Astera Cancer Care — East Brunswick
  • START New York Long Island — Lake Success
  • Sarah Cannon and HCA Research Institute — Nashville
  • MD Anderson Cancer Center — Houston
  • South Texas Accelerated Research Therapeutics (START) — San Antonio

Identifiers

NCT: NCT07462377 · EPI-326-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗