All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Phase I: Multicentre, open-label, two-step single-arm dose escalation study in sequential cohorts of patients with cancer.

Phase II: Prospective, open-label, single-arm, multicentre study of 131I-L19SIP, given at the RD as determined in phase I.

Dosimetric evaluation with 131I-L19SIP will be performed to assess eligibility for Radioimmunotherapy.

Phase I: Patients eligible for Radioimmunotherapy will receive escalating doses of therapeutic 131I-L19SIP administration (intravenously) at the following dosages (expressed in mCi/m2): 111, 139 and 167.

131I-L19SIP Radioimmunotherapy (RIT)

Giuliano Mariani, Prof

Tim Meyer, Dr

The aim of this Study Protocol is to provide a basis for the clinical development of 131I-L19SIP as an anti-cancer therapeutic agent, following the promising results of a Phase I study.

The L19SIP antibody is a fully human antibody, capable of preferential localization around tumor blood vessels while sparing normal tissues. The formation of new blood vessels is a rare event in the adult (exception made for the female reproductive cycle), but is a pathological feature of most aggressive types of cancer. The study aims at determining the therapeutic potential of the L19SIP antibody in SIP format, labelled with the radionuclide 131I, for the treatment of patients with different cancer types. The study follows a Phase I study performed with 131I-L19SIP in over 30 patients with cancer, which has shown an excellent tolerability at radioactive doses as high as 150 mCi and therapeutic benefit for some patients enrolled in the study.

Radioimmunotherapy With 131I-L19SIP in Patients With Cancer

A PHASE I/II DOSE FINDING AND EFFICACY STUDY OF THE TUMOUR TARGETING HUMAN 131I-L19SIP MONOCLONAL ANTIBODY IN PATIENTS WITH CANCER

Establishment of the maximum tolerated dose (MTD) and the recommended dose (RD) for the radiolabelled L19SIP monoclonal antibody.

Investigation of the antitumour activity of 131I-L19SIP at the RD, in patients with advanced cancer.

Evaluation of the pharmacokinetics of 131IL19SIP.

Determination of the overall safety profile of the iodinated antibody characterized by type, frequency, severity, timing and relationship to study therapy of adverse events and laboratory abnormalities in the first and following cycles in all patients receiving a therapeutic dose.

Evaluation of the overall Response Rate (ORR) for all patients having received a therapeutic dose.

Evaluation of the progression free survival (PFS) for all patients having received a therapeutic dose.

Evaluation of the survival rate at 6 and 12 months and overall survival time for all patients having received a therapeutic dose.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Radioimmunotherapy With 131I-L19SIP in Patients With Cancer	NCT01242943	Patients With C...	131I-L19SIP Rad...	18 Years - 75 Years	Philogen S.p.A.
Radioimmunotherapy With 131I-L19SIP in Patients With Cancer	NCT01242943	Patients With C...	131I-L19SIP Rad...	18 Years - 75 Years	Philogen S.p.A.

Spots Global Cancer Trial Database for tumour targeting