68Ga-ABY-025 is used as tracer for PET scan

HER2-positive Breast Cancer

ABY-PET

Section for Clinical Research & Development Unit

A Study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer

A Multicenter Phase II/III-study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer

HER2-expression in tumors measured by 68Ga-ABY-025 PET, centrally analysed and result used for location of biopsy.

HER2-expression in tumors by histopathology. Location of biopsy site based on HER2 expression seen in ABY-PET.

Henrik Lindman

Coordinating Investigator

Roche Pharma AG

Swedish Cancer Society

Affibody

Swedish Breast Cancer Group

Investigators will determine HER2 expression by ABY-PET without knowledge of the results from the biopsies (in Phase III part).

Between 3-9 patients will be administered ABY-029 as a single intravenous injection approximately 1-3 hours prior to surgery.

Head and Neck Cancer

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 operable head and neck cancer approximately 1-3 hours prior to surgery.

ABY-029

Dartmouth-Hitchcock Medical Center

A Microdose Evaluation Study of ABY-029 in Head and Neck Oncology Surgery

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 Operable Head and Neck Cancer.

For each pathology, predictive models of the odds of tumor positivity for biopsies given concentration of ABY-029 will be constructed. Histologically confirmed tumor status from biopsies will be statistically analyzed against the predictive models. The quantitative fluorescence measures will also be assessed for their fit with statistics. The predictive accuracy of the model fit will be summarized through an index.

Regions within the wide-field FI images will be classified as tumor on the basis of their fluorescence signals. Continuous, quantitative optical response data will also be available from the intraoperative probe recordings within the fields-of-view. Two-way classification tables will be examined for agreement between the methods for the "tumor" and "not tumor" categories from an individual patient. Statistical analysis will be used to determine if there is agreement with the region classifications.
In a second analysis, histopathology from biopsies taken at FI-positive and negative sites will be classified as non-tumor tissue, solid tumor, infiltrating tumor, or indeterminate. The positive predictive values of these locations within the wide-field images will be calculated for each individual. These data will also be analyzed for sensitivity and specificity of the fluorescence image signatures relative to the reference standard (histopathology).

Joseph A. Paydarfar

Principal Investigator

Dartmouth College

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

Primary Soft-tissue Sarcoma

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.

A Microdose Evaluation Study of ABY-029 in Primary Sarcoma

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.

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.

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

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.

Eric R. Henderson

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.

Glioma

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.

A Microdose Evaluation Study of ABY-029 in Recurrent Glioma

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 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.

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.

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

David W. Roberts

Breast Cancer

Intravenous injection followed by PET imaging

[68Ga]ABY-025

Uppsala University Hospital

PET Study of Breast Cancer Patients Using [68Ga]ABY-025

An Exploratory Study to Evaluate [68Ga]ABY-025 for PET Imaging of HER2 Expression in Subjects With Metastatic Breast Cancer

Dr. Henrik Lindman, Oncology

Chief Physician

Biomedical Radiation Sciences

Single dose of 100 μg ABY-025 labeled with 500 MBq gallium-68, administrated as a slow intravenous injection. All patients will receive the same dose.

abies beshanzuensis/rak

A Study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer

A Microdose Evaluation Study of ABY-029 in Head and Neck Oncology Surgery

A Microdose Evaluation Study of ABY-029 in Primary Sarcoma

A Microdose Evaluation Study of ABY-029 in Recurrent Glioma

PET Study of Breast Cancer Patients Using [68Ga]ABY-025

HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025

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