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A Microdose Evaluation Study of ABY-029 in Recurrent Glioma

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02901925
Collaborator
Dartmouth College (Other)
12
Enrollment
1
Location
1
Arm
52.5
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Pilot feasibility studyPilot feasibility study
Masking:
None (Open Label)
Masking Description:
open label
Primary Purpose:
Basic Science
Official Title:
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
Actual Study Start Date :
Feb 13, 2017
Actual Primary Completion Date :
Jun 29, 2021
Actual Study Completion Date :
Jun 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: ABY-029

ABY-029 will be administered 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.

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.
Other Names:
  • ABY-029 trifluoroacetate salt
  • IRDye® 800CW Maleimide labeled Affibody peptide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. signal detection [during procedure]

      The primary study endpoint is signal detection (defined as Signal-to-Noise Ratio (SNR) with wide-field iFI) in vivo in brain tissues within the surgical field intended for resection that are subsequently sampled during surgery and assigned an EGFR pathology score based on histological staining.

    Secondary Outcome Measures

    1. diagnostic accuracy of ABY-029 detection [during procedure]

      Diagnostic accuracy of ABY-029 detection will be measured by iFI and intraoperative probe relative to histopathology tissue diagnosis, and other indicators (e.g. proliferation, infiltration, etc.) as the gold standard.

    2. molecular uptake [during procedure]

      molecular uptake and concentration of ABY-029 will be measured in resected specimens.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Preoperative diagnosis of recurrent high-grade glioma having EGFR positive tissue from prior surgery.

    2. Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.

    3. Valid informed consent by subject.

    4. Age ≥ 18 years old.

    Exclusion Criteria:

    1. Pregnant women or women who are breast feeding.

    2. Patients on any experimental anti-EGFR targeted therapies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756

    Sponsors and Collaborators

    • Dartmouth-Hitchcock Medical Center
    • Dartmouth College

    Investigators

    • Principal Investigator: David W Roberts, MD, Dartmouth-Hitchcock Medical Center

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    David W. Roberts, Principal Investigator, Dartmouth-Hitchcock Medical Center
    ClinicalTrials.gov Identifier:
    NCT02901925
    Other Study ID Numbers:
    • D16107
    First Posted:
    Sep 15, 2016
    Last Update Posted:
    Jul 19, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by David W. Roberts, Principal Investigator, Dartmouth-Hitchcock Medical Center
    ABY-029
    Affibody
    Molecular Fluorescence-Guided Surgery
    Epidermal Growth Factor Receptor (EGFR)
    Additional relevant MeSH terms:
    Glioma

    Study Results

    No Results Posted as of Jul 19, 2021