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

RecruitingPhase 1

Sponsor: EpiBiologics

Conditions: Epidermal Growth Factor, Epidermal Growth Factor Receptor, Epidermal Growth Factor Receptor Gene Mutation, Non Small Cell, Non Small Cell Lung

Interventions: EPI-326

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (6)

Los Angeles, California, United States
East Brunswick, New Jersey, United States
Lake Success, New York, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States