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
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant has a life expectancy \> 12 weeks at Day 1.
• Participant has an ECOG performance status of 0-2.
• Participant has pathologically confirmed NSCLC or HNSCC.
• o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion.
• Participant has locally advanced or metastatic NSCLC or HNSCC.
• Participant has adequate organ function
Locations
United States
California
START Los Angeles
NOT_YET_RECRUITING
Los Angeles
New Jersey
Astera Cancer Care
NOT_YET_RECRUITING
East Brunswick
Tennessee
Sarah Cannon and HCA Research Institute
NOT_YET_RECRUITING
Nashville
Texas
MD Anderson Cancer Center
NOT_YET_RECRUITING
Houston
South Texas Accelerated Research Therapeutics (START)
RECRUITING
San Antonio
Contact Information
Primary
EpiBiologics Clinical Trials
clinicaltrials@epibiologics.com
650-955-7486
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2029-07
Participants
Target number of participants: 110
Treatments
Experimental: EPI-326
Experimental: Dose Escalation
Related Therapeutic Areas
Sponsors
Leads: EpiBiologics