A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
Trial Parameters
Brief 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.
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.