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A Microdose Evaluation Study of ABY-029 in Recurrent Glioma (ABY-029)

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ClinicalTrials.gov Identifier: NCT02901925
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : March 5, 2018
Sponsor:
Collaborator:
Dartmouth College
Information provided by (Responsible Party):
David W. Roberts, Dartmouth-Hitchcock Medical Center

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
Glioma Drug: ABY-029 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot 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
Study Start Date : December 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. signal detection [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: during procedure ]
    molecular uptake and concentration of ABY-029 will be measured in resected specimens.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901925


Contacts
Contact: Keith D Paulsen, PhD 603-646-2695 keith.d.paulsen@dartmouth.edu

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
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

Responsible Party: David W. Roberts, Principal Investigator, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02901925     History of Changes
Other Study ID Numbers: D16107
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
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, Dartmouth-Hitchcock Medical Center:
ABY-029
Affibody
Molecular Fluorescence-Guided Surgery
Epidermal Growth Factor Receptor (EGFR)

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue