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ABY-029 Head & Neck Trial
Sponsor: Dartmouth-Hitchcock Medical Center
Summary
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.
Official title: Phase 1 Trial of ABY-029 Fluorescence in Patients With Head and Neck Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-02-28
Completion Date
2028-06-30
Last Updated
2025-12-12
Healthy Volunteers
No
Conditions
Interventions
ABY-029
ABY-029 will be administered via single intravenous injection to subjects with HNSCC approximately 1-3 hours prior to surgery. All research procedures will occur during surgery. The research procedures involve image and measurement data collection and biopsy specimen sampling. Research data collection will occur at 3 or 4 time points during surgery using either standard-of-care tools and methods or non-significant risk experimental devices. No follow-up visit will be required of participants. Participants will be monitored for possible adverse events for approximately 30 days by the operating surgeon involved in the clinical trial procedures and through review of participant medical records.