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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

What is this study?

This study is testing a new experimental medicine called EPI-326 to see if it is safe and effective for treating certain types of lung cancer and head and neck cancer. This is a first-in-human trial, meaning researchers are taking the important first steps to see how patients respond to this new treatment approach.

Who can participate?

You may be eligible if you have advanced non-small cell lung cancer with a specific genetic change (EGFR-mutant) or head and neck cancer. Participants generally need to be active, able to perform daily tasks, and have a life expectancy of at least three months.

What will happen?

As a participant, you will receive the experimental medication EPI-326 in increasing doses to help doctors determine the right amount to give. You will be closely monitored by a medical team throughout the study to check for safety and to see how the cancer responds to the medication.

Where and when?

The study is currently recruiting patients at research centers in Los Angeles (California), East Brunswick (New Jersey), and Lake Success (New York).

Key Points
  • 1Testing a new drug, EPI-326, for specific lung and head/neck cancers.
  • 2This is a Phase 1 study focused on safety and finding the best dosage.
  • 3Participants must meet specific genetic and health criteria to join.

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Conditions Studied
This study is investigating treatments for the following conditions
Epidermal Growth FactorEpidermal Growth Factor ReceptorEpidermal Growth Factor Receptor Gene MutationNon Small CellNon Small Cell LungNon Small Cell Lung CancerHead and NeckHead and Neck CancerHead and Neck CancersHead and Neck Squamous Cell CancerHead and Neck Squamous Cell CarcinomaHead and Neck Squamous Cell Carcinoma HNSCCNSCLC (Non-small Cell Lung Cancer)HNSCCEGFR

This summary was generated using AI and may not capture all details. Always consult with a healthcare professional for medical advice.