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A Microdose Evaluation Study of ABY-029 in Primary Sarcoma

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03154411
Collaborator
Dartmouth College (Other)
12
Enrollment
1
Location
1
Arm
39.4
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary study objective is to determine if microdoses of ABY-029 (up to 6X) lead to detectable signals (defined as signal-to-noise ratio, SNR ≥10, with the Odyssey NIR scanner in sampled tissues with an EGFR pathology score ≥ 1 based on histological staining and compare SNR to tissues with an EGFR pathology score < 1).

The secondary study objective is to assess if the spatial patterns of EGFR expression correlate with the tumor targeting of ABY-029 detection by NIR scanner 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 to enroll a minimum of 6 and a maximum of 12 adult patients with a diagnosis of primary soft-tissue sarcoma in this open label, single center, clinical trial of ABY-029. The study will enroll patients with an EGFR pathology score ≥ 1.

Initial diagnostic biopsy specimens will be analyzed for EGFR positivity by immunohistochemistry following routine diagnostic processing by Pathologist. Patients will be administered a single intravenous dose of ABY-029 1-3 hours before surgery. Following tumor excision, the tumor will be transported to the Pathologist and will be inked and sectioned. Following sectioning the tumor will be imaged using near-infrared imaging systems. Quantitative measurements of fluorophore concentration will be measured for tumors with EGFR pathology score ≥ 1 and compared to those with EGFR pathology score < 1. Quantitative mapping of fluorophore concentration will be correlated with local EGFR concentration and blood vessel density. Upon specimen analysis, fluorophore measurements will be taken from normal, marginal tissues (e.g. skeletal muscle, adipose) in addition to the tumor. Average EGFR concentration and blood vessel density will be determined for each tumor through histological analysis of sections by routine sarcoma protocol and analysis guided by regional variations in ABY-029 concentration based upon near-infrared scan results.

The protocol is not a safety study since no physiological effects are expected at microdose levels of ABY-029. No diagnostic or therapeutic intent is proposed, and administration of the study drug is not intended to alter the extent of planned tumor resection during the surgical procedure.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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 Primary Sarcoma.
Actual Study Start Date :
Aug 30, 2017
Actual Primary Completion Date :
Dec 10, 2020
Actual Study Completion Date :
Dec 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: ABY-029

ABY-029 will be administered prior to surgery and tissue will be examined ex vivo to determine binding with EGFR positive tumor tissue.

Drug: ABY-029
A minimum of 6 and a maximum of 12 adult patients with a diagnosis of primary soft-tissue sarcoma will be enrolled. Initial diagnostic biopsy specimens will be analyzed for EGFR positivity (an EGFR pathology score ≥ 1) by immunohistochemistry following routine diagnostic processing by Pathologist. Patients will be administered a single intravenous dose of ABY-029 1-3 hours before surgery.
Other Names:
  • ABY-029 trifluoroacetate salt
  • IRDye® 800CW Maleimide labeled Affibody peptide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Signal detection [Day of surgery, up to 1 week after surgery]

      Following tumor excision, the tumor will be inked and sectioned and imaged using a near-infrared scanner and fiber-probe based system. Quantitative measurements of fluorophore concentration will be measured for tumors with EGFR pathology score ≥ 1 and compared to those with EGFR pathology score < 1.

    Secondary Outcome Measures

    1. Correlation of spatial patterns of EGFR expression [within 1 week of surgery]

      Quantitative mapping of fluorophore concentration will be correlated with local EGFR concentration and blood vessel density.

    2. molecular uptake and ABY-029 concentration [within 1 week of surgery]

      Fluorophore measurements will be taken from normal, marginal tissues (e.g. skeletal muscle, adipose) in addition to the tumor. Average EGFR concentration and blood vessel density will be determined for each tumor through histological analysis of sections by routine sarcoma protocol and analysis guided by regional variations in ABY-029 concentration based upon near-infrared scan results.

    Eligibility Criteria

    Criteria

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

    1. Preoperative histological diagnosis of primary sarcoma.

    2. Tumor judged to be suitable for open surgical 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, either investigational or FDA approved.

    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: Eric R Henderson, MD, Dartmouth-Hitchcock Medical Center

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Eric R. Henderson, Principal Investigator, Dartmouth-Hitchcock Medical Center
    ClinicalTrials.gov Identifier:
    NCT03154411
    Other Study ID Numbers:
    • D16143
    First Posted:
    May 16, 2017
    Last Update Posted:
    Aug 30, 2021
    Last Verified:
    Aug 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 Eric R. Henderson, Principal Investigator, Dartmouth-Hitchcock Medical Center
    ABY-029
    Affibody
    molecular fluorescence-guided surgery
    Epidermal Growth Factor Receptor (EGFR)
    Additional relevant MeSH terms:
    Sarcoma

    Study Results

    No Results Posted as of Aug 30, 2021