A Microdose Evaluation Study of ABY-029 in Primary Sarcoma

Completed · Early Phase 1

Conditions studied: Primary Soft-tissue Sarcoma

In brief

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.

Key facts

Study ID

NCT03154411

Run by

Dartmouth-Hitchcock Medical Center

People needed

12

Starts

2017-08-30

Expected to finish

2020-12-10

Last updated by the study team

2021-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Preoperative histological diagnosis of primary sarcoma.
• Tumor judged to be suitable for open surgical resection based on preoperative imaging studies.
• Valid informed consent by subject.
• Age ≥ 18 years old.

You may not qualify if…

• Pregnant women or women who are breast feeding.
• Patients on any experimental anti-EGFR targeted therapies, either investigational or FDA approved.

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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