FIBROMUN (L19-TNF)

PH-L19-TNFα-02/07

Study protocol title: Phase I/II study of the tumor-targeting human L19TNFα monoclonal antibody-cytokine fusion protein in patients with advanced solid tumors.

Study purpose: To establish the maximum tolerated dose (MTD) and the recommended dose (RD), the recommended phase II dose and early signs of anticancer activity of L19TNfalpha monotherapy.

Number of patients:

• Phase I: 22 subjects
• Phase II: 12 subjects

Current status:

• Phase I: completed.
• Phase II: completed.

Study centres:

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

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