Clinical Trials /

A Microdose Evaluation Study of ABY-029 in Recurrent Glioma

NCT02901925

Description:

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.

Related Conditions:
  • Glioma
Recruiting Status:

Suspended

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title:A Microdose Evaluation Study of ABY-029 in Recurrent Glioma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: D16107
  • NCT ID: NCT02901925

Trial Conditions

  • Glioma

Trial Interventions

DrugSynonymsArms
ABY-029ABY-029 trifluoroacetate salt, IRDye® 800CW Maleimide labeled Affibody peptide

Trial Purpose

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.

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.

Trial Arms

NameTypeDescriptionInterventions

Eligibility 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

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Both
Healthy Volunteers:No

Primary Outcome Measures

Measure:signal detection
Time Frame:during procedure
Safety Issue:No
Description: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

Measure:diagnostic accuracy of ABY-029 detection
Time Frame:during procedure
Safety Issue:No
Description: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.
Measure:molecular uptake
Time Frame:during procedure
Safety Issue:No
Description:molecular uptake and concentration of ABY-029 will be measured in resected specimens.

Trial Keywords

  • ABY-029
  • Affibody
  • Molecular Fluorescence-Guided Surgery
  • Epidermal Growth Factor Receptor (EGFR)