Perspectives on the phase 0 clinical trial of microdose administration of ABY-029 for fluorescence guided surgery: stability testing

Kimberley S. Samkoe; Sally Hull; Jonathan Elliott; Hira Shahzad Sardar; Jason Gunn; Konstantinos Linos; Laura Tafe; Brent Harris; Joachim Feldwisch; Brian W. Pogue; David Roberts; Eric Henderson; Joseph Paydarfar; Keith Paulsen

doi:10.1117/12.2547110

19 February 2020 Perspectives on the phase 0 clinical trial of microdose administration of ABY-029 for fluorescence guided surgery: stability testing

Kimberley S. Samkoe, Sally Hull, Jonathan Elliott, Hira Shahzad Sardar, Jason Gunn, Konstantinos Linos, Laura Tafe, Brent Harris, Joachim Feldwisch, Brian W. Pogue, David Roberts, Eric Henderson, Joseph Paydarfar, Keith Paulsen

Author Affiliations +

Proceedings Volume 11222, Molecular-Guided Surgery: Molecules, Devices, and Applications VI; 112220X (2020) https://doi.org/10.1117/12.2547110
Event: SPIE BiOS, 2020, San Francisco, California, United States

Abstract

ABY-029, an anti-epidermal growth factor receptor (EGFR) Affibody molecule labeled with IRDye 800CW, has been used in three Phase 0 microdosing clinical trials for fluorescence guided surgery. In May of 2019, the clinical trials were put on hold because the ABY-029 produced under Good Manufacturing Practices (GMP) for human administration had come to the end of term in which the drug product was known to be stable. Stability testing was halted due to limitations in supply of a suitable reference standard and a required test product being discontinued from commercial sale. In order to complete the remaining patients in the three clinical trials, new stability tests were developed and the GMP batch of ABY- 029 drug product tested under the new protocols. The GMP batch of ABY-029 passed all stability tests under the new protocols and the Federal Drug Administration (FDA) has given permission to complete the remaining patients with stability testing of ABY-029 performed for each patient. The tests developed and used to test ABY-029 drug product stability are described here.

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Kimberley S. Samkoe, Sally Hull, Jonathan Elliott, Hira Shahzad Sardar, Jason Gunn, Konstantinos Linos, Laura Tafe, Brent Harris, Joachim Feldwisch, Brian W. Pogue, David Roberts, Eric Henderson, Joseph Paydarfar, and Keith Paulsen "Perspectives on the phase 0 clinical trial of microdose administration of ABY-029 for fluorescence guided surgery: stability testing", Proc. SPIE 11222, Molecular-Guided Surgery: Molecules, Devices, and Applications VI, 112220X (19 February 2020); https://doi.org/10.1117/12.2547110

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