Epidermal Growth Factor study: EPI-326
Official title A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
ClinicalTrials.gov ID: NCT07462377
What this study is testing
What is EPI-326?
EPI-326 is an investigational antibody being studied as a potential treatment for EGFR‑driven cancers such as head and neck squamous cell carcinoma and non‑small cell lung cancer. EPI-326 is designed to bind selectively to EGFR‑expressing tissues and recruit immune cells to attack cancer cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe and well tolerated EPI‑326 is, and whether it shows early signs of fighting tumors.
- Who it's for
- Adults with advanced or metastatic head‑and‑neck squamous cell cancer or EGFR‑mutant non‑small cell lung cancer.
- What's involved
- Participants receive increasing doses of EPI‑326, with regular visits, blood tests, and imaging to monitor safety and tumor response.
- Time commitment
- The study lasts about 6–12 weeks of treatment, with follow‑up visits every few weeks.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant has a life expectancy \> 12 weeks at Day 1.
- Participant has an ECOG performance status of 0-2.
- Participant has pathologically confirmed NSCLC or HNSCC. o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion.
- Participant has locally advanced or metastatic NSCLC or HNSCC.
- Participant has adequate organ function
You likely can't join if
- Participant has 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 patients treated with curative intent...
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- East Brunswick, New Jersey, United States
- Lake Success, New York, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Seoul, South Korea
- Kaohsiung City, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; East Brunswick, New Jersey, United States; Lake Success, New York, United States; Nashville, Tennessee, United States; Houston, Texas, United States; San Antonio, Texas, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.