A Microdose Evaluation Study of ABY-029 in Head and Neck Oncology Surgery

• Status: Completed
• Trial end date: 2020-12-18
• Target enrollment: 0
• Participant gender: All

Summary

The primary study objective is to determine if microdoses of ABY-029 (up to 6X) lead to detectable signals (defined as signal-to-noise ratio, SNR ≥10, with wide-field iFI) in sampled tissues with an EGFR (epidermal growth factor receptor) pathology score ≥ 1 based on histological staining.

The secondary study objective is to assess ex vivo the specificity of tumor binding in resected specimens by measuring the corresponding molecular uptake and concentrations using histopathology.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: Dartmouth College

Criteria

Inclusion Criteria:

1. Preoperative diagnosis of head and neck cancer.

2. Tumor judged to be operable based on preoperative imaging studies.

3. Valid informed consent by subject or subject's Legally Authorized Representative.

4. Age ≥ 18 years old.

Exclusion Criteria:

1. Pregnant women or women who are breast feeding.

2. Patients on any experimental anti-EGFR targeted therapies, either investigational or FDA approved.