This clinical contract supports the design and conduct of Phase I/II clinical trials of monoclonal antibodies, immunoconjugates and other targeting agents alone or in combination with other investigational or standard therapy. This is a shared contract between the Division of Cancer Treatment, Biological Resources Branch, and the Cancer Therapy Evaluation Branch. These trials will focus on studies of mechanisms of anti-tumor response and immune modulation. Current areas of emphasis include the elucidation of complex interactions between the biological agent(s), the host effector cells and the tumor which may lead to tumor regression. Thus, ADCC, TIL activation, and the induced inflammatory response will be under scrutiny. In addition, detailed studies will be performed of pharmacokinetics and biodistribution, which are intended to lead to better application of monoclonal antibodies to deliver radionuclides, toxins and drugs to tumor cell targets. Of special interest will be the influence on these processes of specific modifications of monoclonal antibodies, such as changes in affinity, isotype, chimerization and substitution of F(ab')2 fragments.
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