RADRETUMAB (L19-I131)

PH-L19-I131SIP-07/07

Study protocol title: A phase I/II dose finding and efficacy study of the tumor targeting human 131I-L19SIP monoclonal antibody in patients with cancer.

Study purpose:

• Phase I: To establish the maximum tolerated dose (MTD) and the recommended dose (RD) for the radiolabelled L19SIP monoclonal antibody.

• Phase II: To investigate the antitumor activity of 131I-L19SIP at the RD, in patients with advanced cancer.

Number of patients:

• Phase I: Up to 18 patients (depending on occurrence of Dose Limiting Toxicities) will be enrolled;

• Phase II: A maximum of 50 evaluable patients will be enrolled.

Current status: Completed. Final study report in preparation.

Study centres:

• Azienda Ospedaliero Universitaria Pisana Centro Regionale di Medicina Nucleare Dipartimento Universitario di Oncologia, dei trapianti e delle nuove Tecnologie in Medicina Via Roma 67 – 56126 – Pisa, Italy.

• Istituto Scientifico Romagnolo per lo studio e la cura dei tumori – IRST, Via Piero Maroncelli 40 – 47014 – Meldola (FC), Italy.

• UCL Cancer Institute, Paul O'Gorman Building, University College London, 72 Huntley Street London, WC1E 6BT, UK.