DARLEUKIN (L19-IL2)

PH-L19-IL2-01/05

Study protocol title: Dose Finding Pharmacokinetic Study of the Tumour-Targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Patients with Advanced Solid Tumours

Study purpose: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of the human L19IL2 fusion-cytokine. To determine the qualitative and quantitative toxicity profile. To determine the pharmacokinetic profile. To assess the presence of anti-fusion protein antibodies in treated patients. To evaluate the safety profile of repeated administrations of L19IL2 in patients treated at the RD. To identify early signs of antitumour activity.

Number of patients: During the five stages of dose escalation, 21 patients were enrolled. A further 12 patients were enrolled in the expansion cohort at the recommended dose.

Current status: Completed.

Study centers:

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

• Department of Urology, Charité, Universitätsmedizin Berlin, Germany.