drugset / Trial / NCT01240720

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

NCT01240720 ↗

Phase 1/2 Completed 65 enrolled Philogen S.p.A. Eudax S.r.l. · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2008-09
Primary completion
2011-11
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject 131I-F16SIP Monoclonal antibody 5 mg Intravenous
Subject 131I-F16SIP Monoclonal antibody 10 mg Intravenous
Subject 131I-F16SIP Monoclonal antibody 55.5 unknown Intravenous

Indications