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

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.