A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC

ConditionsEpidermal 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

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorEpiBiologics

About this trial

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 criteria

Qualifiers

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.

Participant has locally advanced or metastatic NSCLC or HNSCC.

Disqualifiers

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 design

Treatments tested in this trial

EPI-326

Treatment groups

110 Participants

are divided into 1 treatment group

Locations

START Los Angeles90025, Los AngelesCalifornia, United States

Astera Cancer Care08816, East BrunswickNew Jersey, United States

START New York Long Island11042, Lake SuccessNew York, United States

Sarah Cannon and HCA Research Institute37203, NashvilleTennessee, United States

Sponsors and collaborators

EpiBiologics

Lead sponsor

Source ClinicalTrials.gov