Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
ABY-029, Affibody, Molecular Fluorescence-Guided Surgery, Epidermal Growth Factor Receptor (EGFR)
Brief 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.
Interventions
DRUGABY-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.
Sponsors
Dartmouth-Hitchcock Medical Center
Dartmouth College
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Twelve (12) participants with likely EGFR-positive tumors will be enrolled, alternating between two ABY-029 administration doses (the 6X dose and 10X dose), until a total of 24 participants have been enrolled.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Preoperative diagnosis of head and neck squamous cell carcinoma with planned surgical resection of the oral cavity, oropharynx, larynx, or hypopharynx. 2. Tumor judged to be operable. 3. Valid informed consent by participant. 4. Age ≥ 18 years old. 5. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
1. Patients with a medical history of (Grade 2 or higher) hepatic/renal function compromise. 2. Prisoners 3. Individuals who are pregnant or breast feeding. 4. Patients on experimental or approved anti-EGFR targeted therapies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events related to ABY-029 | one month | To study the safety of ABY-029, adverse events related to 6X and 10X doses of ABY-029 will be tracked following surgery, and the proportion of study-drug related adverse events at 6X and 10X doses will be compared statistically for significant differences. |
| Diagnostic accuracy of measured ABY-029 fluorescence ex-vivo in surgical specimens | up to three months | To measure the diagnostic performance of ABY-029, the diagnostic accuracy of measured ABY-029 fluorescence ex-vivo in surgical specimens histologically confirmed as tumor from participants receiving the 6X microdose and 10X microdose. |
Contacts
CONTACTKeith D Paulsen, PhD
CONTACTJoseph Paydarfar, MD
PRINCIPAL_INVESTIGATORJoseph Paydarfar, MD
Dartmouth-Hitchcock Medical Center
Outcome results
None listed