NCT02053324

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

Terminated Phase 1 Last updated 5 July 2019

What this trial tests

Phase 1 trial testing AvidinOX/ST2210 in Liver Metastases in 14 participants. Terminated before completion.

Timeline

11 November 2013

Primary endpoint
1 June 2019

1 July 2019

Quick facts

Lead sponsor	Alfasigma S.p.A.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	11 November 2013
Primary completion	1 June 2019
Estimated completion	1 July 2019
Sites	4 locations across Austria, Italy

Drugs / interventions tested

• AvidinOX/ST2210

Conditions studied

• Liver Metastases — all drugs for Liver Metastases →

Sponsor

Alfasigma S.p.A. — full company profile →

Who can join

Adults 18 to 75, any sex, with Liver Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pretargeting: A Path Forward for Radioimmunotherapy.
   Cheal SM, Chung SK, Vaughn BA, Cheung NV, et al · · 2022 · cited 54× · PMID 36215514 · DOI 10.2967/jnumed.121.262186
2. Efficacy of aerosol therapy of lung cancer correlates with EGFR paralysis induced by AvidinOX-anchored biotinylated Cetuximab.
   De Santis R, Rosi A, Anastasi AM, Chiapparino C, et al · · 2014 · cited 10× · PMID 25238453 · DOI 10.18632/oncotarget.2409
3. Radionuclide Therapy of Unresectable Tumors with AvidinOX and (90)Y-biotinDOTA: Tongue Cancer Paradigm.
   Albertoni C, Leoni B, Rosi A, D'Alessio V, et al · · 2015 · cited 9× · PMID 26167947 · DOI 10.1089/cbr.2015.1837
4. 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.
   Milazzo FM, Anastasi AM, Chiapparino C, Rosi A, et al · · 2017 · cited 6× · PMID 28186982 · DOI 10.18632/oncotarget.15145
5. Intra-tumor AvidinOX allows efficacy of low dose systemic biotinylated Cetuximab in a model of head and neck cancer.
   Vesci L, Milazzo FM, Anastasi AM, Petronzelli F, et al · · 2016 · cited 4× · PMID 26575422 · DOI 10.18632/oncotarget.6089
6. 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.
   Vesci L, Carollo V, Rosi A, De Santis R. · · 2019 · cited 1× · PMID 30867794 · DOI 10.3892/ol.2019.10003