A Microdose Evaluation Study of ABY-029 in Primary Sarcoma

• Status: Completed
• Trial end date: 2020-12-10
• 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 the Odyssey NIR scanner in sampled tissues with an EGFR pathology score ≥ 1 based on histological staining and compare SNR to tissues with an EGFR pathology score < 1).

The secondary study objective is to assess if the spatial patterns of EGFR expression correlate with the tumor targeting of ABY-029 detection by NIR scanner relative to histopathology diagnosis, and other indicators (e.g. proliferation, infiltration, etc.) as the gold standard, and to measure the molecular uptake and concentration of ABY-029 in resected specimens.

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

Details

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

Criteria

Inclusion Criteria:

1. Preoperative histological diagnosis of primary sarcoma.

2. Tumor judged to be suitable for open surgical resection based on preoperative imaging studies.

3. Valid informed consent by subject.

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.