Clinical Trials: Overview

The clinical program at GSCC currently focuses on the use of radiolabeled antibodies for detection and treatment of a variety of cancers. The trials conducted at GSCC and its affiliated sites are phase I or phase II. This reflects the developmental and translational clinical research that the Center is primarily engaged in at this time. These trials obtain basic information concerning the tolerability, biodistribution, clearance behavior, and radiation dosimetry for the antibody in question, and they enable a preliminary assessment of the anti-tumor efficacy of these agents. With this set of data, comparisons can be made between antibodies or to the antibody radiolabeled with different radionuclides. This is an extremely important part of the process of assessing the optimal agent to select for more advanced clinical studies, whether they be for imaging or therapy applications.

These types of studies have resulted in the selection of optimal antibodies for imaging and treatment of cancers expressing carcinoembryonic antigen (CEA), a target antigen not found in normal, healthy cells. Pilot studies of genetically engineered “humanized”-antibodies showed that their targeting properties were quite similar to that of the parent mouse antibody, and provided clear evidence of their reduced immunogenicity. Humanized-MN-14 anti-CEA antibody is currently in clinical trials for the treatment of ovarian cancer. New antibodies to colorectal, pancreatic, prostate, lung, breast, melanoma, and multiple myeloma cancers are being developed and tested. It is anticipated that some of these new antibodies will be in pilot or phase I clinical imaging and therapy trials in the upcoming year.

With a strong emphasis on translational research, the Center provides a unique environment for basic researchers to observe first-hand if their theories or hypotheses can be applied directly to solve clinical problems. In turn, the clinicians become intimately involved in developmental research. This approach will continue to play an important role in the future by development of new programs and recruitment of new scientists and clinicians who embrace this type of interactive program. Indeed, this is a particular strength of the GSCC; namely, the rapid translation of laboratory developments into clinical investigation and eventually, general practice.