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A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
NCT07462377 · EpiBiologics
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 110 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04
Estimated completion: 2029-07
Last updated: 2026-03-25
Interventions
Drug: EPI-326
Primary outcomes
- • Evaluation of the safety and tolerability of EPI-326 (Up to 3 years.)
- • Determination of the recommended dose and schedule for EPI-326 administration (Up to 3 years.)
Sponsor
EpiBiologics · industry
Contacts & investigators
ContactEpiBiologics Clinical Trials · contact · clinicaltrials@epibiologics.com · 650-955-7486
All locations (5)
START Los AngelesNot Yet Recruiting
Los Angeles, California, United States
Astera Cancer CareNot Yet Recruiting
East Brunswick, New Jersey, United States
Sarah Cannon and HCA Research InstituteNot Yet Recruiting
Nashville, Tennessee, United States
MD Anderson Cancer CenterNot Yet Recruiting
Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START)Recruiting
San Antonio, Texas, United States