A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
Sponsored by EpiBiologics
About this study
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.
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 single agent administered to patients with EGFR-mutant (per clinically validated molecular testing, e.g., next-generation sequencing \[NGS\]) locally advanced or metastatic NSCLC and locally advanced or metastatic HNSCC. All patients will be treated until documented disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Where this study is enrolling (6)
- I'm interested
Site 105 - START Los Angeles
Los Angeles, California
- I'm interested
Site 104 - START New Jersey
East Brunswick, New Jersey
- I'm interested
Site 107 - START New York - Long Island
Lake Success, New York
- I'm interested
Sarah Cannon and HCA Research Institute
Nashville, Tennessee
- I'm interested
MD Anderson Cancer Center
Houston, Texas
Show all 6 locations
- I'm interested
Site 102 - START San Antonio
San Antonio, Texas
Who can participate
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.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.