Neoplasm Clinical Trial
Official title:
A Phase I Open-Label Safety and Pharmacokinetic Study of Escalating Doses of SGT-53 for Infusion in Subjects With Advanced Solid Tumors
This is a Phase Ib study as a continuation of the original Phase I protocol. The purpose of this Phase Ib study is to evaluate the safety of a single course of SGT-53 in combination with docetaxel and determine the recommended Phase II doses of SGT-53 and docetaxel in combination for evaluation in subsequent clinical studies for the treatment of solid tumors.
The p53 gene is a vital tumor suppressor gene in humans. Numerous human tumors possess a
loss or mutation of wild type p53 (wtp53). In addition to playing a crucial role in cell
cycle control, the p53 gene is a critical component in two of the pathways involved in
regulating tumor cell growth: cell death (apoptosis) and the regulation of angiogenesis. The
loss of such critical tumor suppressor activity is believed to be responsible for p53's
involvement in such a broad array of human tumors and resistance to chemo/radiotherapy.
SGT-53 is a complex composed of a wild type p53 gene (plasmid DNA) encapsulated in a
liposome that is targeted to tumor cells by means of an anti-transferrin receptor
single-chain antibody fragment (TfRscFv) attached to the outside of the liposome.
Pre-clinical studies have indicated that SGT-53 could sensitize tumors to the effects of
radiation/chemotherapy.
The Phase 1a portion of this clinical study was designed to evaluate the safety and maximum
tolerated dose (MTD) of SGT-53. In addition, pharmacokinetics of escalating doses of SGT-53
will be measured and correlated with tumor response and toxicity.
The Phase Ib portion of this clinical study is designed to evaluate the safety of SGT-53 in
combination with docetaxel, determine the recommended Phase II doses of these two agents,
and evaluate the effect of the combination of SGT-53 and docetaxel on tumor size or
progression.
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