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RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early study tests increasing doses of EPI-326 to learn about its safety, side effects, how it works in the body, and whether it fights cancer. It is for people with non-small cell lung cancer (NSCLC) with an EGFR gene change, or head and neck squamous cell cancer (HNSCC), that has spread nearby or to other parts of the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Expected to live more than 12 weeks from the first day of the study.
  • Able to do all or most daily tasks, or able to care for yourself and be up more than half the day (ECOG score 0–2).
  • Have NSCLC or HNSCC confirmed by lab testing of tissue or cells.
  • For NSCLC, the cancer must have a confirmed change in the EGFR gene.
  • Cancer has spread nearby or to other parts of the body.
  • Organs are working well enough for the study.

Who can't join

  • Have a history of an illness that is not under control.
  • Have cancer that has spread to the brain and is causing symptoms.
  • Were diagnosed with another cancer within the past 3 years, unless it was treated with the goal of curing it and there are no signs of active cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Participant has a life expectancy \> 12 weeks at Day 1. 2. Participant has an ECOG performance status of 0-2. 3. Participant has pathologically confirmed NSCLC or HNSCC. o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion. 4. Participant has locally advanced or metastatic NSCLC or HNSCC. 5. Participant has adequate organ function Exclusion Criteria: 1. Participant has history of uncontrolled illness. 2. Participant has symptomatic brain metastases. 3. 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.

Study sites (6)

CA

NJ

NY

TN

TX