ABY-029 Head & Neck Trial

NCT ID: NCT07279116

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2028-06-30

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ABY-029 6X dose group

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.

Group Type: EXPERIMENTAL

ABY-029

Intervention Type: 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.

ABY-029 10X dose group

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.

Group Type: EXPERIMENTAL

ABY-029

Intervention Type: 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.

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth College

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joseph A. Paydarfar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Paydarfar, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Central Contacts

Keith D Paulsen, PhD

Role: CONTACT

keith.d.paulsen@dartmouth.edu

603-646-2695

Joseph Paydarfar, MD

Role: CONTACT

joseph.a.paydarfar@hitchcock.org

603-650-8123

Other Identifiers

R01CA167413

Identifier Type: NIH

Identifier Source: secondary_id

View Link

02002698

Identifier Type: -

Identifier Source: org_study_id