drugset / Trial / NCT03154411

A Microdose Evaluation Study of ABY-029 in Primary Sarcoma

NCT03154411 ↗

NaSingle-groupOpen-labelBasic science

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.

Timeline

Start
2017-08-30
Primary completion
2020-12-10
Completion
2020-12-10

Drugs

EvaluationDrugModalityDoseRoute
Subject ABY-029 Peptide — Intravenous

Indications