Actively Recruiting
A First-in-Human, Open-Label Phase 1 Study of EPI-326 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma
Led by EpiBiologics · Updated on 2026-05-08
110
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and early anti-tumor activity of increasing doses of EPI-326 in patients with locally advanced or metastatic head and neck squamous cell carcinoma (HNSCC) or epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC). This Phase 1 study is the first to test EPI-326 in humans and aims to understand how the drug behaves and affects these cancers. Participants will receive EPI-326 as a single agent through intravenous infusion in a dose escalation design to find the recommended dose and schedule. Treatment will continue until the disease progresses, unacceptable side effects occur, the participant withdraws consent, or the study ends. The study is open-label and conducted at multiple centers. During the study, participants will be monitored for safety and tolerability of EPI-326 for up to three years. Blood samples will be taken to measure drug levels and how the body processes it. Researchers will also assess tumor response, including the objective response rate and duration of response. Participants' organ function and overall health status will be evaluated regularly to ensure safety throughout the study period.
CONDITIONS
Brief Title
A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy greater than 12 weeks at Day 1
- ECOG performance status of 0 to 2
- Pathologically confirmed non-small cell lung cancer (NSCLC) or head and neck squamous cell carcinoma (HNSCC)
- For NSCLC, tumor must have a documented EGFR mutation, insertion, or deletion
- Locally advanced or metastatic NSCLC or HNSCC
- Adequate organ function
You will not qualify if you...
- History of uncontrolled illness
- Symptomatic brain metastases
- Diagnosis of any secondary malignancy within 3 years prior to enrollment, except those treated with curative intent and no active disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years
Participants receive EPI-326 administered via intravenous infusion to treat EGFR-mutant non-small cell lung cancer or head and neck squamous cell carcinoma. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Trial Site Locations
Total: 6 locations
1
START Los Angeles
Los Angeles, California, United States, 90025
Actively Recruiting
2
Astera Cancer Care
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
3
START New York Long Island
Lake Success, New York, United States, 11042
Not Yet Recruiting
4
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
5
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
6
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
E
EpiBiologics Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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