A Microdose Evaluation Study of ABY-029 in Recurrent Glioma (ABY-029)
November 20, 2024 updated by: David W. Roberts, Dartmouth-Hitchcock Medical Center
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pregnant women or women who are breast feeding.
- Patients on any experimental anti-EGFR targeted therapies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ABY-029 1X dose group
ABY-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.
|
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.
Other Names:
|
|
Experimental: ABY-029 3X dose group
ABY-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.
|
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.
Other Names:
|
|
Experimental: ABY-029 6X dose group
ABY-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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fluorescence Signal Detection
Time Frame: during procedure
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Tumor-to-background Ratio
Time Frame: during procedure
|
A secondary study endpoint is to calculate the ratio of the average (mean) fluorescence intensity of ABY-029 measured in the tumor, to the average (mean) fluorescence intensity of ABY-029 measured in the surrounding tissues in the brain during surgery.
This will help researchers determine how well ABY-029 works for imaging tumor tissue.
|
during procedure
|
|
Ex Vivo Fluorescence Intensity
Time Frame: post surgical
|
Another secondary study endpoint is to quantify the relationship between the dose of ABY-029 administered and the fluorescence intensity produced by ABY-029 in ex vivo tissue samples after they have been transferred to the pathology department.
This endpoint will be measured in relative fluorescence units, and will help researchers conduct analyses on how well ABY-029 works for imaging in tissue following surgery.
|
post surgical
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David W Roberts, MD, Dartmouth-Hitchcock Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 13, 2017
Primary Completion (Actual)
June 29, 2021
Study Completion (Actual)
June 29, 2021
Study Registration Dates
First Submitted
September 12, 2016
First Submitted That Met QC Criteria
September 14, 2016
First Posted (Estimated)
September 15, 2016
Study Record Updates
Last Update Posted (Actual)
December 13, 2024
Last Update Submitted That Met QC Criteria
November 20, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D16107
- R01CA167413 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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