A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
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
EpiBiologics
110 participants
Apr 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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
Exclusion Criteria3
- 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.
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Interventions
EPI-326 is a tissue-selective bispecific antibody for EGFR-driven cancers. EPI-326 will be administered in the clinic via IV infusion.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT07462377