Actively Recruiting
A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
Led by EpiBiologics · Updated on 2026-05-08
110
Participants Needed
6
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has a life expectancy greater than 12 weeks at Day 1
- Participant has an ECOG performance status of 0-2
- Participant has pathologically confirmed NSCLC or HNSCC
- For NSCLC: tumor harbors any documented EGFR mutation, insertion, or deletion
- Participant has locally advanced or metastatic NSCLC or HNSCC
- Participant has adequate organ function
You will not qualify if you...
- Participant has a history of uncontrolled illness
- Participant has symptomatic brain metastases
- Participant has a diagnosis of any secondary malignancy within 3 years prior to enrollment, except for those treated with curative intent and no evidence of active disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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