Details of the SBP

General Information of Synthetic Binding Protein (SBP) (ID: SBP000005)
SBP Name
Affibody ABY-025
Synonyms
ABY025; [111In]ABY-025; [68Ga]ABY-025
Design Method Traditional methods (Site-directed mutagenesis and/or Directed evolution)
Highest Status Phase III
Protein Scaffold Information of This SBP
Scaffold ID PS004
Scaffold Info
[1]
Scaffold Name Affibody
Scaffold Class Non-Antibody
Fold Type Three Alpha-Helices
Binding Target(s) of This SBP (BTS)
BTS Name Details Mechanism Application Affinity Research Organization Ref
Receptor tyrosine-protein kinase erbB-2
BTS Info
Binder Imaging agent for patients with breast cancer Kd: 0.076 nM Affibody AB; Uppsala University [1]
Clinical Trial Information of This SBP
EUCTR2017-002115-34-SE Click to show the Detail
Indication Advanced Breast Cancer
Phase Phase II; Phase III
Title A multicenter phase II/III-study of 68Ga-ABY-025 PET for non-invasive quantification of HER2-expression in advanced breast cancer-Affibody-3
Status Authorised
Sponsor Region Uppsala
NCT01216033 Click to show the Detail
Indication Metastatic Breast Cancer
Phase Phase I; Phase II
Title An Exploratory Study to Evaluate the Distribution of [111In]ABY-025?Uptake for SPECT Imaging in Subjects With Metastatic Breast Cancer
Status Completed
Sponsor Biomedical Radiation Sciences
NCT01858116 Click to show the Detail
Indication Metastatic Breast Cancer
Phase Phase I; Phase II
Title An Exploratory Study to Evaluate [68Ga]ABY-025?for PET Imaging of HER2 Expression in Subjects With Metastatic Breast Cancer
Status Completed
Sponsor Biomedical Radiation Sciences
NCT02095210 Click to show the Detail
Indication Breast Cancer
Phase Phase I
Title Phase I Study, Evaluating HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025
Status Terminated
Sponsor Dorte Nielsen
NCT03655353 Click to show the Detail
Indication Advanced Breast Cancer
Phase Not Applicable
Title A Multicenter Phase II/III-study of 68Ga-ABY-025?PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer
Status Recruiting
Sponsor Henrik Lindman
NCT05619016 Click to show the Detail
Indication Esophageal Neoplasms; Gastric Neoplasms Malignant; Breast Cancer; HER2-positive Gastric Cancer
Phase Phase II
Title [68Ga]Ga-ABY-025 PET for Quantification of HER2-status in Solid Tumors
Status Recruiting
Sponsor Karolinska University Hospital
References
1 In vitro-engineered non-antibody protein therapeutics. Protein Cell. 2018 Jan;9(1):3-14.