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

RecruitingPhase 1Ages 18 Years - anyAllEpiBiologics
NCT07462377 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • EPI-326
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Where

8 sites
Site 105 - START Los Angeles
Los Angeles, United States
Site 104 - START New Jersey
East Brunswick, United States
Site 107 - START New York - Long Island
Lake Success, United States
Sarah Cannon and HCA Research Institute
Nashville, United States
MD Anderson Cancer Center
Houston, United States
Site 102 - START San Antonio
San Antonio, United States
Samsung Medical Center
Seoul, South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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