Spots Global Cancer Trial Database for A Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer
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Trial Identification
Brief Title: A Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer
Official Title: A Phase I/II Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer
Study ID: NCT01240720
Conditions
Interventions
Study Description
Brief Summary: The aim of this Study Protocol is to provide a basis for the clinical development of 131I-F16SIP as an anti-cancer therapeutic agent. The study follows and is greatly motivated by the promising results of a Phase I/II study with a similar investigational drug developed by our Company, 131I-L19SIP, in several Italian centers.
Detailed Description: The F16SIP antibody is a fully human antibody, capable of preferential localization around tumour 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 F16 antibody in SIP format,labelled with the radionuclide 131I, for the treatment of patients with different cancer types.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospital Pisa, Pisa, Tuscany, Italy
Policlinico S. Orsola-Malpighi- Azienda Ospedaliero-Universitaria di Bologna, Bologna, , Italy
ASUR Zona Territoriale 9, Medicina Nucleare Ospedale di Macerata, Macerata, , Italy
Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Meldola (Fc), Meldola, , Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Di Napoli, Napoli, , Italy
Arcispedale Santa Maria Nuova Di Reggio Emilia, Reggio Emilia, , Italy
Contact Details
Name: Maddalena Sansovini, Dr
Affiliation: IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori)
Role: PRINCIPAL_INVESTIGATOR
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