A Phase I Imaging and Pharmacodynamic Trial of CS-1008 in Patients With Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2012-06-27
Target enrollment:
Participant gender:
Summary
This was a Phase 1, open-label, single-center study of CS-1008, an immunoglobulin G subclass
1 (IgG1) humanized monoclonal antibody, in subjects with advanced colorectal carcinoma who
had received ≥ 1 prior chemotherapy regimen for metastatic disease. Primary study objectives
were to determine the influence of the CS-1008 dose on the biodistribution, pharmacokinetics
(PK) and tumor uptake of radiolabeled CS-1008 following a single infusion and following
continuous sequential doses of CS-1008. Secondary objectives were to evaluate changes in
tumor metabolism, antitumor response, and changes in serum apoptosis biomarkers and tumor
response markers following treatment with CS-1008.