[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614401":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":24,"responsibleParty":38,"collaborators":41,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":24,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":24,"enrollmentInfo":56,"targetDuration":24,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":69,"whyStopped":24,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":24},{"fullName":5,"class":6},"Dartmouth-Hitchcock Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ABY-029 6X dose group","EXPERIMENTAL","ABY-029 will be administered at the 6X dose level prior to surgery to participants with HNSCC.\n\nTo 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.",[13],"Drug: ABY-029",{"label":15,"type":10,"description":16,"interventionNames":17},"ABY-029 10X dose group","ABY-029 will be administered at the 10X dose level prior to surgery to participants with HNSCC.\n\nTo 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.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","ABY-029","ABY-029 will be administered via single intravenous injection to subjects with HNSCC approximately 1-3 hours prior to surgery.\n\nAll 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.\n\nNo 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.",[15,9],null,[26],{"name":27,"affiliation":5,"role":28},"Joseph Paydarfar, MD","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Keith D Paulsen, PhD","CONTACT","603-646-2695","keith.d.paulsen@dartmouth.edu",{"name":27,"role":32,"phone":36,"phoneExt":24,"email":37},"603-650-8123","joseph.a.paydarfar@hitchcock.org",{"type":28,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Joseph A. Paydarfar","Principal Investigator",[42,44],{"name":43,"class":6},"Dartmouth College",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH","100614401","phase-1-aby-029-head--neck-trial-100614401",false,"NCT07279116","ABY-029 Head & Neck Trial","Phase 1 Trial of ABY-029 Fluorescence in Patients With Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Preoperative diagnosis of head and neck squamous cell carcinoma with planned surgical resection of the oral cavity, oropharynx, larynx, or hypopharynx.\n2. Tumor judged to be operable.\n3. Valid informed consent by participant.\n4. Age ≥ 18 years old.\n5. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patients with a medical history of (Grade 2 or higher) hepatic\u002Frenal function compromise.\n2. Prisoners\n3. Individuals who are pregnant or breast feeding.\n4. Patients on experimental or approved anti-EGFR targeted therapies.","ALL","18 Years",{"count":57,"type":58},24,"ESTIMATED","INTERVENTIONAL",[61],"PHASE1","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.",[64],"Head and Neck Squamous Cell Carcinoma",[21,66,67,68],"Affibody","Molecular Fluorescence-Guided Surgery","Epidermal Growth Factor Receptor (EGFR)","NOT_YET_RECRUITING","2026-05-05",{"date":72,"type":73},"2026-05-07","ACTUAL",{"date":75,"type":58},"2026-06-30",{"date":77,"type":58},"2028-06-30",{"name":5,"class":6}]