Epidermal Growth FactorPhase 1NCT07462377
A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
A Phase 1 study testing EPI-326 in people with Epidermal Growth Factor and Epidermal Growth Factor Receptor, run by EpiBiologics at 8 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epidermal Growth Factor, Epidermal Growth Factor Receptor, Epidermal Growth Factor Receptor Gene Mutation
- What is being tested?
- EPI-326
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 31 Mar 2026to Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
United States6 sites, 6 recruiting
- Recruiting
Site 104 - START New Jersey
East Brunswick, New Jersey, 08816
HOPE Team, 732-426-4750, hopeteam@startresearch.com
Dr. Bruno Fang
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
EpiBiologics Clinical Trials, 650-955-7486, clinicaltrials@epibiologics.com
- Recruiting
Site 107 - START New York - Long Island
Lake Success, New York, 11042
HOPE Team, 363-207-5160, hopeteam@startresearch.com
Dr. Geraldine O'Sullivan Coyne
- Recruiting
Site 105 - START Los Angeles
Los Angeles, California, 90025
HOPE Team, 210-593-5250, hopeteam@startreseach.com
Dr. Navid Hafez
- Recruiting
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, 37203
EpiBiologics Clinical Trials, 650-955-7486, clinicaltrials@epibiologics.com
- Recruiting
Site 102 - START San Antonio
San Antonio, Texas, 78229
HOPE Team, 210-593-5250, hopeteam@startreseach.com
Dr. Kyriakos Papadopoulos
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
EpiBiologics Clinical Trials, 650-955-7486, clinicaltrials@epibiologics.com
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, 80756
Hui-Ching Wang, hcwang@kmu.edu.tw;joellewang66@gmail.com
About this study
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
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.
Read the detailed description
This study will be a first-in-human (FIH), Phase 1, multicenter, open-label study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 as a single agent administered to patients with EGFR-mutant (per clinically validated molecular testing, e.g., next-generation sequencing [NGS]) locally advanced or metastatic NSCLC and locally advanced or metastatic HNSCC. All patients will be treated until documented disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
- Conditions
- Epidermal Growth Factor, Epidermal Growth Factor Receptor, Epidermal Growth Factor Receptor Gene Mutation, Non Small Cell, Non Small Cell Lung, Non Small Cell Lung Cancer
- Being tested
- EPI-326
- Keywords
- Head and Neck Squamous Cell Carcinoma, HNSCC, Epidermal Growth Factor Receptor Gene Mutation, EGFR, Non Small Cell Lung Cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPI-326Drug
Also called EPI-326 Injection
EPI-326 is a tissue-selective bispecific antibody for EGFR-driven cancers. EPI-326 will be administered in the clinic via IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| EPI-326 | Experimental | Experimental: Dose Escalation Receives: Drug: EPI-326 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety and tolerability of EPI-326
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicity (DLTs).
Measured: Up to 3 years.
Determination of the recommended dose and schedule for EPI-326 administration
Maximum tolerated dose (MTD), maximum administered dose (MAD).
Measured: Up to 3 years.
Secondary outcomes (6)
Determination of maximum (Cmax) and minimum (Cmin) plasma concentration
Drug concentration in the blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326.
Measured: Up to 3 years.
Determination of area under the concentration-time curve (AUC)
Drug concentration in blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326
Measured: Up to 3 years.
Determination of clearance (CL) from the blood
Drug concentration in blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326
Measured: Up to 3 years.
Determination of volume of distribution (Vd)
Drug concentration in blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326
Measured: Up to 3 years.
Objective response rate (ORR)
Measured: Up to 3 years.
Duration of response (DOR)
Measured: Up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start31 Mar 2026
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermal Growth FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EpiBiologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462377
- Sponsor's protocol ID
- EPI-326-001
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07462377
- Acronym / sponsor ID
- EPI-326-001
- Conditions
- Epidermal Growth Factor, Epidermal Growth Factor Receptor, Epidermal Growth Factor Receptor Gene Mutation, Non Small Cell, Non Small Cell Lung, Non Small Cell Lung Cancer
- Keywords
- Head and Neck Squamous Cell Carcinoma, HNSCC, Epidermal Growth Factor Receptor Gene Mutation, EGFR, Non Small Cell Lung Cancer, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- EpiBiologicsIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a first-in-human (FIH), Phase 1, multicenter, open-label study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 as a single agent administered to patients with EGFR-mutant (per clinically validated molecular testing, e.g., next-generation sequencing [NGS]) locally advanced or metastatic NSCLC and locally advanced or metastatic HNSCC. All patients will be treated until documented disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPI-326 | Experimental | Drug: EPI-326Experimental: Dose Escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPI-326Also: EPI-326 InjectionEPI-326 is a tissue-selective bispecific antibody for EGFR-driven cancers. EPI-326 will be administered in the clinic via IV infusion. | Drug | EPI-326 |
Primary outcome
Evaluation of the safety and tolerability of EPI-326
Time frame: Up to 3 years.
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicity (DLTs).
Determination of the recommended dose and schedule for EPI-326 administration
Time frame: Up to 3 years.
Maximum tolerated dose (MTD), maximum administered dose (MAD).
6 secondary outcomes
Determination of maximum (Cmax) and minimum (Cmin) plasma concentration
Time frame: Up to 3 years.
Determination of area under the concentration-time curve (AUC)
Time frame: Up to 3 years.
Determination of clearance (CL) from the blood
Time frame: Up to 3 years.
Determination of volume of distribution (Vd)
Time frame: Up to 3 years.
Objective response rate (ORR)
Time frame: Up to 3 years.
Duration of response (DOR)
Time frame: Up to 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EPI-326 in people with Epidermal Growth Factor and Epidermal Growth Factor Receptor, run by EpiBiologics at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EpiBiologics Clinical Trials (650-955-7486, clinicaltrials@epibiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the safety and tolerability of EPI-326 (time frame: Up to 3 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.