Status:
RECRUITING
A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
Lead Sponsor:
EpiBiologics
Conditions:
Epidermal Growth Factor
Epidermal Growth Factor Receptor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Detailed Description
This study will be a first-in-human (FIH), Phase 1, multicenter, open-label study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 as a ...
Eligibility Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
- Participant has history of uncontrolled illness.
- Participant has symptomatic brain metastases.
- 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.
Key Trial Info
Start Date :
April 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07462377
Start Date
April 1 2026
End Date
July 1 2029
Last Update
March 25 2026
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
START Los Angeles
Los Angeles, California, United States, 90025
2
Astera Cancer Care
East Brunswick, New Jersey, United States, 08816
3
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, United States, 37203
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030