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This Phase Ib/II study is an openlabel, multicenter study for patients with solid tumors and breast cancer amenable to anthracyclin therapy.
The study is divided in two parts:
Phase I: an open-label, dose escalation study of F16IL2 in combination with doxorubicin for patients with solid tumors.
Phase II: a prospective, single-arm, multicentre study of a fixed dose of F16IL2 in combination with doxorubicin, equivalent to stage 1 of the Simon two-stage phase II design, for patients with breast cancer amenable to anthracyclin therapy.
F16IL2 is a recombinant fusion protein composed of a fully human recombinant monoclonal antibody (F16), and human recombinant interleukin-2 (IL-2).
Tenascin - C (TN-C) is an extracellular matrix glycoprotein whose overexpression is associated with neoplastic tissues. The protein is coded by a single gene and it's expression is regulated by a single promoter (Carnemolla et al 1999). Structurally different isoforms are generated by alternative splicing of the TN-C transcript and splice variants, normally absent in adult tissues, become more predominant and over expressed in cancer stroma (Takatsugu et al (2003). The large isoform of Tenascin - C represents probably the best tumour-associated antigen of breast cancer described so far. Research performed by various independent groups has shown that large TN-C variants are preferentially expressed in breast cancer tissues and that they are closely associated with the migration and proliferation of breast cancer cells. ScFv(F16) is a human recombinant antibody fragment in the scFv (single chain Fragment variable) format that is directed against tenascin C, an angiogenesis marker common to most solid tumors independent of the tumor type. ScFv(F16) selectively localizes in tumor tissues in animal models as demonstrated both histologically and during mechanistic studies involving mice transfected with orthotopic human tumours.
IL2, the human cytokine interleukin-2, is a potent stimulator of the immune response. It has a central role in the regulation of T cell responses and effects on other immune cells such as natural killer cells, B cells, monocyte/macrophages and neutrophils (Smith, 1988). IL2 can induce tumor regression through its ability to stimulate a potent cell-mediated immune response in vivo (Rosenberg, 2000).
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Advanced Solid Tumor
F16IL2 in combination with doxorubicin
A.O. UNIVERSITARIA OSPEDALI RIUNITI - OSPEDALE UMBERTO I DI ANCONA - ANCONA (AN) (Italy)
Published on BioPortfolio: 2014-08-27T03:13:22-0400
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Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.
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