A Microdose Evaluation Study of ABY-029 in Recurrent Glioma
ABY-029
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
2 other identifiers
interventional
14
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Feb 2017
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2016
CompletedFirst Posted
Study publicly available on registry
September 15, 2016
CompletedStudy Start
First participant enrolled
February 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2021
CompletedResults Posted
Study results publicly available
December 13, 2024
CompletedDecember 13, 2024
August 1, 2024
4.4 years
September 12, 2016
August 31, 2024
November 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fluorescence Signal Detection
The primary study endpoint is to determine if the fluorescence signal from ABY-029, as measured by Biological Variance Ratio (BVR), can be detected in brain tissue during surgery. This will help researchers determine if ABY-029 functions well for imaging brain tumor tissue during surgery.
during procedure
Secondary Outcomes (2)
Mean Tumor-to-background Ratio
during procedure
Ex Vivo Fluorescence Intensity
post surgical
Study Arms (3)
ABY-029 1X dose group
EXPERIMENTALABY-029 will be administered at the 1X dose level prior to surgery. Probe will be used in vivo to determine if signal is detectable, and ex vivo tissue pathology will measure extent of binding with EGFR positive tumor tissue.
ABY-029 3X dose group
EXPERIMENTALABY-029 will be administered at the 3X dose level prior to surgery. Probe will be used in vivo to determine if signal is detectable, and ex vivo tissue pathology will measure extent of binding with EGFR positive tumor tissue.
ABY-029 6X dose group
EXPERIMENTALABY-029 will be administered at the 6X dose level prior to surgery. Probe will be used in vivo to determine if signal is detectable, and ex vivo tissue pathology will measure extent of binding with EGFR positive tumor tissue.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Preoperative diagnosis of recurrent high-grade glioma having EGFR positive tissue from prior surgery.
- Tumor judged to be suitable for open cranial 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dartmouth-Hitchcock Medical Centerlead
- Dartmouth Collegecollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. David Roberts
- Organization
- Dartmouth-Hitchcock
Study Officials
- PRINCIPAL INVESTIGATOR
David W Roberts, MD
Dartmouth-Hitchcock Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- open label
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 12, 2016
First Posted
September 15, 2016
Study Start
February 13, 2017
Primary Completion
June 29, 2021
Study Completion
June 29, 2021
Last Updated
December 13, 2024
Results First Posted
December 13, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share