A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
Recruiting · NCT07462377 · Interventional (participants receive a specific treatment) · Lead sponsor: EpiBiologics
View the official record on ClinicalTrials.gov →Interventions studied
EPI-326
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- 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
Exclusion criteria
- 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 and no evidence of active disease.
Where it is running
6 locations listed across 5 US states.
- Site 105 - START Los Angeles - Los Angeles, California, United States
- Site 104 - START New Jersey - East Brunswick, New Jersey, United States
- Site 107 - START New York - Long Island - Lake Success, New York, United States
- Sarah Cannon and HCA Research Institute - Nashville, Tennessee, United States
- MD Anderson Cancer Center - Houston, Texas, United States
- Site 102 - START San Antonio - San Antonio, Texas, United States