NCT07462377 A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
| NCT ID | NCT07462377 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | EpiBiologics |
| Condition | Epidermal Growth Factor |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 110 participants in total. It began in 2026-03-31 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07462377 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Epidermal Growth Factor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07462377 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07462377 currently recruiting?
Yes, NCT07462377 is actively recruiting participants. Contact the research team at clinicaltrials@epibiologics.com for enrollment information.
Where is the NCT07462377 trial being conducted?
This trial is being conducted at Los Angeles, United States, East Brunswick, United States, Lake Success, United States, Nashville, United States and 2 additional locations.
Who is sponsoring the NCT07462377 clinical trial?
NCT07462377 is sponsored by EpiBiologics. The trial plans to enroll 110 participants.