RecruitingPhase 1

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

United States110 participantsStarted 2026-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Participant has adequate organ function

Exclusion criteria

✕. 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.

What they're measuring

Evaluation of the safety and tolerability of EPI-326

Timeframe: Up to 3 years.

Determination of the recommended dose and schedule for EPI-326 administration

Timeframe: Up to 3 years.

Trial details

NCT IDNCT07462377

SponsorEpiBiologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-07

Contact for this trial

EpiBiologics Clinical Trials

650-955-7486 clinicaltrials@epibiologics.com

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