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 (6) 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
RECRUITING
Los Angeles
New Jersey
Astera Cancer Care
RECRUITING
East Brunswick
New York
START New York Long Island
RECRUITING
Lake Success
Tennessee
Sarah Cannon and HCA Research Institute
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: 2026-03-31
Estimated Completion Date: 2029-07
Participants
Target number of participants: 110
Treatments
Experimental: EPI-326
Experimental: Dose Escalation
Related Therapeutic Areas
Sponsors
Leads: EpiBiologics