Cancer Clinical Trial
Official title:
A Phase I/II Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer
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.
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. ;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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