Epidermal Growth FactorEpidermal Growth Factor ReceptorEpidermal Growth Factor Receptor Gene MutationNon Small CellNon Small Cell LungNon Small Cell Lung CancerHead and NeckHead and Neck CancerHead and Neck CancersHead and Neck Squamous Cell CancerHead and Neck Squamous Cell CarcinomaHead and Neck Squamous Cell Carcinoma HNSCCNSCLC (Non-small Cell Lung Cancer)HNSCCEGFR
Investigational drug(s) / intervention(s)
EPI-326
EPI-326: EPI-326 is a tissue-selective bispecific antibody for EGFR-driven cancers. EPI-326 will be administered in the clinic via IV infusion.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Evaluation of the safety and tolerability of EPI-326 — Up 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 administration — Up to 3 years. Maximum tolerated dose (MTD), maximum administered dose (MAD).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.