The use of implantation of human tumors to animals has facilitated the identification of most clinically active anticancer agents and has made a major and definitive contribution to the development of efficacious therapies. HD Biosciences has developed and validated more than 30 different subcutaneous and orthotopic human tumor xenografts to evaluate the antitumor effects of selected antitumor agents. Therapeutic efficacy is assessed based on the effects of test agents on tumor size and tumor growth rate in tumor-bearing nude mice in comparison with vehicle-treated control animals. Athymic mice (nu/nu) are inoculated (s.c.) in the flank with either human tumor cells or tumor fragments, which are allowed to grow to 100-200 mm3, then treated for weeks with the anticancer agents. Tumor volume and growth inhibition (%TGI) will be calculated. Body weight, surviving rate, and biomarker will be monitored. Histological analysis of tumor tissue will be performed to confirm the target engagement. Toxicity of treatment will be evaluated as needed.