TELEUKIN (F16-IL2)

PH-F16-IL2DOXO-04/07

Study protocol title: A dose-finding, pharmacokinetic, Phase Ib/II study of the tumor-targeting human F16IL2 monoclonal antibody-cytokine fusion protein in combination with doxorubicin in patients with advanced solid tumors.

Study purpose:

• Phase Ib: To establish the maximum tolerated dose (MTD) and the recommended dose (RD) of F16IL2 when administered in combination with doxorubicin.

• Phase II: To investigate the efficacy of F16IL2 in combination with doxorubicin in breast cancer patients amenable to anthracyclin therapy.

Number of patients:

• Phase Ib: 18 enrolled patients.

• Phase II: A maximum of 20 patients will be enrolled.

Current status:

• Phase Ib: completed.

• Phase II: Open.

Study centres:

• Istituto Europeo di Oncologia di Milano, Unità di Farmacologia Clinica e Nuovi Farmaci dell’Istituto, Via Ripamonti 435 - 20141 Milano, Italy.

• A.O. Universitaria Ospedali Riuniti, Ospedale Umberto I di Ancona, Clinica di Oncologia Medica, Via Conca, 71 – 60020 Torrette di Ancona, Italy.

• Azienda Ospedaliera Universitaria di Modena, Dept. Oncologia, Ematologia e Patologie dell’apparato respiratorio, Via del Pozzo 71 - 41100 Modena, Italy.

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

• University Hospital of Siena, Division of Medical Oncology, Strada delle Scotte n° 14 – 53100 Siena, Italy.