A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
Public ClinicalTrials.gov record NCT07462377. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07462377
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 110 participants
Conditions and interventions
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
- Head and Neck
- Head and Neck Cancer
- Head and Neck Cancers
- Head and Neck Squamous Cell Cancer
- Head and Neck Squamous Cell Carcinoma
- Head and Neck Squamous Cell Carcinoma HNSCC
- NSCLC (Non-small Cell Lung Cancer)
- HNSCC
- EGFR
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2026 (Actual)
- Primary completion
- Jul 2029 (Estimated)
- Completion
- Jul 2029 (Estimated)
- Last update posted
- Oct 14, 2026
2026 – 2029
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 105 - START Los Angeles | Los Angeles | California | 90025 | Recruiting |
| Site 104 - START New Jersey | East Brunswick | New Jersey | 08816 | Recruiting |
| Site 107 - START New York - Long Island | Lake Success | New York | 11042 | Recruiting |
| Sarah Cannon and HCA Research Institute | Nashville | Tennessee | 37203 | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| Site 102 - START San Antonio | San Antonio | Texas | 78229 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07462377, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07462377 live on ClinicalTrials.gov.