ABY-029 Head & Neck Trial
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
The purposes of the research trial are to study the safety of ABY-029 and to understand how much of the drug is needed to reach head and neck squamous cell carcinomas (HNSCC) so it can be visualized best by surgeons. Investigators will do this by comparing two groups of participants that receive different, very small amounts of ABY-029. Investigators will use an imaging system during surgery to record the amount of ABY-029 in the participant's tumor and in the surrounding tissue.
Eligibility criteria
Qualifiers
Preoperative diagnosis of head and neck squamous cell carcinoma with planned surgical resection of the oral cavity, oropharynx, larynx, or hypopharynx.
Tumor judged to be operable.
Valid informed consent by participant.
Age ≥ 18 years old.
Disqualifiers
Patients with a medical history of (Grade 2 or higher) hepatic/renal function compromise.
Prisoners
Individuals who are pregnant or breast feeding.
Patients on experimental or approved anti-EGFR targeted therapies.
Trial design
Treatments tested in this trial
- ABY-029
Treatment groups
24 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Dartmouth-Hitchcock Medical Center
Lead sponsor
Dartmouth College
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov