EPI-326 for EGFR-mutant non-small cell lung cancer and head and neck squamous cell carcinoma
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
This phase 1 trial will try EPI-326, a new drug, in people with EGFR-mutant non‑small cell lung cancer or advanced head and neck squamous cell carcinoma to find safe doses, study how the body handles it, and look for early signs it shrinks tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EpiBiologics Industry-sponsored |
| Locations | 6 sites (Los Angeles, California and 5 other locations) |
| Trial ID | NCT07462377 on ClinicalTrials.gov |
What this trial studies
This first-in-human, multicenter, open-label Phase 1 dose-escalation trial will give ascending single-agent doses of EPI-326 to patients with EGFR-mutant locally advanced or metastatic NSCLC and to patients with locally advanced or metastatic HNSCC. The primary focus is on safety and tolerability while collecting pharmacokinetic and pharmacodynamic data, along with preliminary anti-tumor activity. Eligible NSCLC participants must have a documented EGFR mutation by clinically validated testing; all participants must have adequate organ function and an ECOG performance status of 0–2. Patients will remain on treatment until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Who should consider this trial
Good fit: Ideal candidates are adults with pathologically confirmed locally advanced or metastatic HNSCC or NSCLC harboring a documented EGFR mutation, with ECOG 0–2, life expectancy over 12 weeks, and adequate organ function.
Not a fit: Patients without EGFR mutations, those with symptomatic brain metastases, uncontrolled illnesses, recent second malignancies within three years, poor organ function, or inability to attend the listed U.S. sites are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, EPI-326 could offer a new targeted treatment option for patients with EGFR-mutant NSCLC or advanced HNSCC and may improve disease control with an acceptable safety profile.
How similar studies have performed: This is a first-in-human trial of EPI-326, although other EGFR-targeted therapies such as tyrosine kinase inhibitors and antibodies have shown clear benefit in EGFR-mutant NSCLC, while targeted approaches in HNSCC have been less consistently effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California and 5 other locations
- START Los Angeles — Los Angeles, California, United States (Recruiting)
- Astera Cancer Care — East Brunswick, New Jersey, United States (Recruiting)
- START New York Long Island — Lake Success, New York, United States (Not_yet_recruiting)
- Sarah Cannon and HCA Research Institute — Nashville, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Not_yet_recruiting)
- South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: EpiBiologics Clinical Trials
- Email: clinicaltrials@epibiologics.com
- Phone: 650-955-7486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.