NCT02901925

A Microdose Evaluation Study of ABY-029 in Recurrent Glioma

A Phase 0 Open Label, Single-center Clinical Trial of ABY-029, an Anti-EGFR Fluorescence Imaging Agent Via Single Intravenous Injection to Subjects With Recurrent Glioma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary study objective is to determine if microdoses of ABY-029 lead to detectable signals in sampled tissues with an EGFR pathology score ≥ 1 based on histological staining. The secondary study objective is to assess diagnostic accuracy of ABY-029 detection by iFI and intraoperative probe 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.

Detailed description

The investigators plan a sample size of 6-12 patients in this open label, single center, clinical trial of ABY-029. Administration will occur as a single intravenous injection to subjects with recurrent glioma, approximately 1-3 hours prior to surgery. The protocol is not a safety study since no physiological effects are expected at microdose levels of ABY-029. Rather, doses have been selected to determine if a fluorescence signal can be detected by wide-field imaging technology with a signal-to-noise ratio of 10, which is considered necessary for subsequent assessment of diagnostic performance of ABY-029 as a tumor biomarker sufficient to guide surgical resection in the future. No diagnostic or therapeutic intent is proposed, and administration of the study drug is not intended to alter the extent of planned brain tumor resection during the surgical procedure.

Conditions

• Glioma

Interventions

Type	Name	Description
DRUG	ABY-029	Using a sample size of 6-12 patients, ABY-029 will be administered via single intravenous injection to subjects with recurrent glioma, approximately 1-3 hours prior to surgery. Microdose levels of ABY-029 have been selected to determine if a fluorescence signal can be detected by wide-field imaging technology with a signal-to-noise ratio of 10, which is considered necessary for subsequent assessment of diagnostic performance of ABY-029 as a tumor biomarker sufficient to guide surgical resection in the future. Administration of the study drug is not intended to alter the extent of planned brain tumor resection during the surgical procedure.

Timeline

• Start date: 2017-02-13
• Primary completion: 2021-06-29
• Completion: 2021-06-29
• First posted: 2016-09-15
• Last updated: 2024-12-13
• Results posted: 2024-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study