NCT01240720

A Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer

A Phase I/II Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Philogen S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this Study Protocol is to provide a basis for the clinical development of 131I-F16SIP as an anti-cancer therapeutic agent. The study follows and is greatly motivated by the promising results of a Phase I/II study with a similar investigational drug developed by our Company, 131I-L19SIP, in several Italian centers.

Detailed description

The F16SIP antibody is a fully human antibody, capable of preferential localization around tumour blood vessels while sparing normal tissues. The formation of new blood vessels is a rare event in the adult (exception made for the female reproductive cycle), but is a pathological feature of most aggressive types of cancer. The study aims at determining the therapeutic potential of the F16 antibody in SIP format,labelled with the radionuclide 131I, for the treatment of patients with different cancer types.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	131I-F16SIP Radioimmunotherapy (RIT)	* Dosimetric evaluation with 131I-F16SIP or 124I-F16SIP will be performed to assess eligibility for Radioimmunotherapy. * Patients eligible for Radioimmunotherapy will receive 55.5 mCi/m2 as established in the Phase I part of the study. A single dose of 5 to 10 mg of 131I-F16SIP will be administered intravenously (I.V).

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-11-01
• Completion: 2013-04-01
• First posted: 2010-11-15
• Last updated: 2014-02-25

Locations

6 sites across 1 country: Italy