Phase 1 Study of EPI-326 for EGFR-mutant NSCLC and HNSCC
This Phase 1 study is testing a new drug called EPI-326 for people with certain types of cancer. EPI-326 is a special antibody designed to target cancers driven by EGFR (Epidermal Growth Factor Receptor) mutations. You might be able to join if you have locally advanced or metastatic (spread to other parts of the body) non-small cell lung cancer (NSCLC) with an EGFR mutation, or head and neck squamous cell carcinoma (HNSCC). The main goals are to see how safe EPI-326 is, how well your body tolerates it, and to find the best dose. This study is currently open, and plans to enroll about 110 people.
- Study design
- This is a Phase 1, open-label study, meaning both you and your doctors will know what treatment you are receiving. It plans to enroll about 110 participants.
- What's involved
- You will receive EPI-326 as an IV infusion in the clinic. Treatment will continue until your disease gets worse, side effects are too severe, you choose to stop, or the study ends.
- Compensation
- Not stated in the trial record.
- Follow-up
- The safety and tolerability of EPI-326 will be measured for up to 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
At a glance
Conditions
Where it's being run
6 sites across 5 statesWho to contact
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What this trial measures
- Evaluation of the safety and tolerability of EPI-326Up to 3 years.
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicity (DLTs).
- Determination of the recommended dose and schedule for EPI-326 administrationUp to 3 years.
Maximum tolerated dose (MTD), maximum administered dose (MAD).