EPI-326 for Advanced Head and Neck or Lung Cancer

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

Recruiting Phase 1 Interventional Study
Epidermal 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
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
110 (estimated)
Sponsor
EpiBiologics · Industry
Who this trial is looking for

This trial is looking for patients with advanced head and neck cancer or lung cancer caused by an EGFR mutation. Participants will receive doses of EPI-326 to help determine its safety and effects on their cancer.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have a life expectancy of more than 12 weeks.
  • I have a performance status of 0-2.
  • I have been diagnosed with lung cancer or head and neck cancer.
  • My lung cancer has an EGFR mutation.
  • I have locally advanced or metastatic lung cancer or head and neck cancer.
  • I have adequate organ function.

You may not be able to join if

  • I have a history of uncontrolled illness.
  • I have symptomatic brain metastases.
  • I have been diagnosed with another cancer in the past 3 years, except if it was treated completely and there is no active disease.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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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.

Trial Locations
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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 ha…
Contacts

EpiBiologics Clinical Trials

650-955-7486

clinicaltrials@epibiologics.com

CONTACT