A First-in-Human, Open-label, Multicenter, Phase I Study of EPI-326 in Patients With Epidermal Growth Factor Receptor-Mutant Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma

Study Identifier:
EPI-326-001
CT.gov Identifier:
NCT07462377
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruiting

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Study Summary

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.

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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Gene Mutatations
  • Non-Small Cell Lung Cancer
  • Head & Neck
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Gene Mutatations
    Non-Small Cell Lung Cancer
    Head & Neck
    Location
    START New Jersey
    East Brunswick, NJ, United States, 08816
    Investigator
    Bruno Fang
    Status
    Recruiting
    Condition(s) Treated at Site
    Gene Mutatations
    Non-Small Cell Lung Cancer
    Head & Neck
    Location
    START Los Angeles
    Los Angeles, CA, United States, 90025
    Investigator
    Navid Hafez
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Gene Mutatations
    Non-Small Cell Lung Cancer
    Head & Neck