EPI-326 for EGFR-mutant non-small cell lung cancer and head and neck squamous cell carcinoma
Official title: 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
Run by EpiBiologics · NCT07462377 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | EpiBiologics Industry-sponsored |
| Locations | 8 sites (Los Angeles, California and 7 other locations) |
| Status | Recruiting |
| Started | March 31, 2026 |
| Main results expected | July 2029 |
| Study ends | July 2029 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT07462377 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Site 105 - START Los Angeles
Los Angeles, California, United States Recruiting -
Site 104 - START New Jersey
East Brunswick, New Jersey, United States Recruiting -
Site 107 - START New York - Long Island
Lake Success, New York, United States Recruiting -
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, United States Recruiting -
MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
Site 102 - START San Antonio
San Antonio, Texas, United States Recruiting
Show 2 more locations
-
Samsung Medical Center
Seoul, South Korea Recruiting -
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, Taiwan Recruiting
Study contacts
- Study coordinator: EpiBiologics Clinical Trials
- Email: clinicaltrials@epibiologics.com
- Phone: 650-955-7486
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluating a new CAR T-cell therapy for solid tumors expressing EGFR
This study is testing a new CAR T-cell therapy to see if it can safely help adults with certain solid tumors, like colorectal and lung cancer, that have specific markers.
-
Treatment of solid tumors or lymphoma with VMD-928
This study is testing a new oral medication called VMD-928 to see if it can help adults with advanced solid tumors or lymphoma that haven't improved with standard treatments.
-
Selective dose reduction of neck radiation in HPV-associated oropharyngeal cancer
This trial tests whether lowering radiation doses to certain neck lymph nodes or gross disease areas is safe and can reduce side effects for adults with HPV-related oropharyngeal cancer.
-
Injecting a viral particle to treat head and neck cancer
This study is testing a new virus injection to see if it can help treat head and neck cancer in different groups of patients.
-
Combining chemotherapy and immunotherapy for head and neck cancer treatment
This study is testing if combining chemotherapy with immunotherapy drugs can help people with head and neck cancer before surgery and possibly reduce the need for radiation therapy afterward.
-
Evaluating PC14586 for advanced solid tumors with a specific mutation
This study is testing a new oral medication called PC14586 to see if it can help people with advanced solid tumors that have a specific mutation in the TP53 gene.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.