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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA167413 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABY-029 6X dose group | Experimental | 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. |
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| ABY-029 10X dose group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABY-029 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events related to ABY-029 | 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. | one month |
| Diagnostic accuracy of measured ABY-029 fluorescence ex-vivo in surgical specimens | 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. | up to three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keith D Paulsen, PhD | Contact | 603-646-2695 | keith.d.paulsen@dartmouth.edu | |
| Joseph Paydarfar, MD | Contact | 603-650-8123 | joseph.a.paydarfar@hitchcock.org |
| Name | Affiliation | Role |
|---|---|---|
| Joseph Paydarfar, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000626949 | ABY-029 |
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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.
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| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |