ABY-029 for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Joseph Paydarfar, MD
Principal Investigator
Dartmouth-Hitchcock Medical Center
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) diagnosed with head and neck squamous cell carcinoma who are scheduled for surgery to remove their tumor. Participants must be able to understand the study and agree in writing to take part.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- ABY-029
Trial Overview
The study tests ABY-029, a drug given in very small amounts before surgery, to see how well it helps surgeons visualize tumors using a special imaging system. Two groups will get different low doses of ABY-029.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
ABY-029 will be administered at the 6X dose level prior to surgery to participants with HNSCC. To understand the safety of ABY-029, investigators will collect blood samples before and after surgery at these time points: before the drug is given to the participant, one or two minutes after participants are given the drug, about 15 minutes after participants are given the drug, and just prior to anesthesia. Investigators will also collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery.
ABY-029 will be administered at the 10X dose level prior to surgery to participants with HNSCC. To understand the safety of ABY-029, investigators will collect blood samples before and after surgery at these time points: before the drug is given to the participant, one or two minutes after participants are given the drug, about 15 minutes after participants are given the drug, and just prior to anesthesia. Investigators will also collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dartmouth-Hitchcock Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Dartmouth College
Collaborator
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