A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- EpiBiologics
- Study ID
- NCT07462377
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- EGFR
- Epidermal Growth Factor
- Epidermal Growth Factor Receptor
- Epidermal Growth Factor Receptor Gene Mutation
- HNSCC
- 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)
- Non Small Cell
- Non Small Cell Lung
- Non Small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- EPI-326 — DRUGEPI-326 is a tissue-selective bispecific antibody for EGFR-driven cancers. EPI-326 will be administered in the clinic via IV infusion.
Study Details
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.
Key Dates
- First listed
- Mar 10, 2026
- Start date
- Mar 31, 2026
- Status verified
- Sep 2026
- Primary completion
- Jul 31, 2029
- Completion
- Jul 31, 2029
Study Design
- Enrollment
- 110 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: EPI-326Experimental: Dose Escalation
Primary Outcome Measure
Evaluation of the safety and tolerability of EPI-326 [ Time Frame: Up to 3 years. ]
Central Contacts
- EpiBiologics Clinical Trials650-955-7486
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Site 105 - START Los Angeles | Los Angeles | California | 90025 | Dr. Navid Hafez (PRINCIPAL_INVESTIGATOR) |
| Site 104 - START New Jersey | East Brunswick | New Jersey | 08816 | Dr. Bruno Fang (PRINCIPAL_INVESTIGATOR) |
| Site 107 - START New York - Long Island | Lake Success | New York | 11042 | Dr. Geraldine O'Sullivan Coyne (PRINCIPAL_INVESTIGATOR) |
| Sarah Cannon and HCA Research Institute | Nashville | Tennessee | 37203 | |
| MD Anderson Cancer Center | Houston | Texas | 77030 | |
| Site 102 - START San Antonio | San Antonio | Texas | 78229 | Dr. Kyriakos Papadopoulos (PRINCIPAL_INVESTIGATOR) |
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