AvidinOX + [177Lu]DOTA-biotin (or 177Lu-ST2210) Complex in Patients With Liver Metastases From Colorectal Cancer

Summary

The purpose of the study is to assess a new treatment for patients with liver tumor metastases from colorectal cancer. The treatment has never been used in humans before. The treatment foresees the use of two compounds: AvdinOX and \[177Lu\]DOTA-biotin. AvidinOX is a new compound, essentially a natural protein obtained from hen eggs, while \[177Lu\]DOTA-biotin is a new chemical compound resulting from the combination of the DOTA-biotin (also deriving from a natural vitamin which is biotin) with the 177Lutetium, an atom which emits radiation. AvidinOX will be injected directly into the metastases in the liver and \[177Lu\]DOTA-biotin will be injected into the arm vein. One specific property of AvidinOX is that it chemically links to the tumor tissues when it is injected while maintaining the capacity to take up \[177Lu\]DOTA-biotin. Once locally bound in tumor tissue, AvidinOX becomes an "artificial receptor" for intravenously injected \[177Lu\]DOTA-biotin, which allows an internal radiation therapy of the tumor tissue. The treatment of liver metastases with local injection of AvidinOX and the following intra-venous injection of \[177Lu\]DOTA-biotin could be simpler and more tolerable than the current available treatments.

Timeline

Start

2013-11-11

Primary completion

2019-06-01

Completion

2019-07-01

Outcome

Outcome not reported

Stopped (Enrollment): “Low recruitment rate”

Publications

• Vesci L, Carollo V, Rosi A, De Santis R. Therapeutic efficacy of intra-tumor AvidinOX and low systemic dose biotinylated cetuximab, with and without cisplatin, in an orthotopic model of head and neck cancer. Oncol Lett. 2019 Mar;17(3):3529-3536. doi: 10.3892/ol.2019.10003. Epub 2019 Feb 1.
• Milazzo FM, Anastasi AM, Chiapparino C, Rosi A, Leoni B, Vesci L, Petronzelli F, De Santis R. AvidinOX-anchored biotinylated trastuzumab and pertuzumab induce down-modulation of ErbB2 and tumor cell death at concentrations order of magnitude lower than not-anchored antibodies. Oncotarget. 2017 Apr 4;8(14):22590-22605. doi: 10.18632/oncotarget.15145.
• Vesci L, Milazzo FM, Anastasi AM, Petronzelli F, Chiapparino C, Carollo V, Roscilli G, Marra E, Luberto L, Aurisicchio L, Pacello ML, Spagnoli LG, De Santis R. Intra-tumor AvidinOX allows efficacy of low dose systemic biotinylated Cetuximab in a model of head and neck cancer. Oncotarget. 2016 Jan 5;7(1):914-28. doi: 10.18632/oncotarget.6089.
• Albertoni C, Leoni B, Rosi A, D'Alessio V, Carollo V, Spagnoli LG, van Echteld C, De Santis R. Radionuclide Therapy of Unresectable Tumors with AvidinOX and (90)Y-biotinDOTA: Tongue Cancer Paradigm. Cancer Biother Radiopharm. 2015 Sep;30(7):291-8. doi: 10.1089/cbr.2015.1837. Epub 2015 Jul 13.

Drugs

Indications