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

NCT02053324 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-07-05

No results posted yet for this study

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.

Conditions

  • Liver Metastases

Interventions

COMBINATION_PRODUCT

AvidinOX/ST2210

One intralesion injection of AvidinOX followed by an intravenous infusion of ST2210

Sponsors & Collaborators

  • Alfasigma S.p.A.

    lead INDUSTRY

Principal Investigators

  • Alexander Haug, MD · Allgemeines Krankenhaus Wien (Austria)

  • Andreas Wicki, MD · Universitatsspital Basel (Switzerland)

  • Francesco Scopinaro, MD · St. Andrea Hospital Rome (Italy)

  • Roberto Cianni, MD · S Maria Goretti Hospital - Latina (Italy)

  • Michele Sicolo, MD · Dell'Angelo Hospital - Mestre (Italy)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-11
Primary Completion
2019-06-01
Completion
2019-07-01

Countries

  • Austria
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02053324 on ClinicalTrials.gov