We are conducting a research study for tumors that have not responded to prior treatment. The subject will receive an investigational drug called IMC-1121B. ImClone LLC, the maker of IMC-1121B, is running this research study. We believe that IMC-1121B blocks the growth factors made by the cancer cells, so new blood vessels do not grow. It is believed that without the new blood vessels, the cancer or tumor will not get the oxygen and food that it needs to grow. This may stop the cancer from growing or spreading and the tumor cells may die. Since normal blood vessels have already formed in adults, it might be possible to stop tumor growth without harming normal cells.
We are conducting a research study for tumors that have not responded to prior treatment. The subject will receive an investigational drug called IMC-1121B. ImClone LLC, the maker of IMC-1121B, is running this research study. In order for a cancer to grow, it needs blood vessels to bring to it oxygen and food. Cancer cells can make growth factors that cause the abnormal growth of new blood vessels. This is called angiogenesis. Normally, new blood vessels do not grow in adults. Angiogenesis inhibitors are drugs that may prevent abnormal growth of blood vessels to tumors. IMC-1121B is an angiogenesis inhibitor. We believe that IMC-1121B blocks the growth factors made by the cancer cells, so new blood vessels do not grow. It is believed that without the new blood vessels, the cancer or tumor will not get the oxygen and food that it needs to grow. This may stop the cancer from growing or spreading and the tumor cells may die. Since normal blood vessels have already formed in adults, it might be possible to stop tumor growth without harming normal cells.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Cohort 1 6 mg/kg I.V., once every other week for 4 weeks
Cohort 2 8mg/kg I.V., once every other week for 4 weeks
Cohort 3 10 mg/kg I.V., once every other week for 4 weeks
Cohort 4 15 mg/kg I.V., once every 3 weeks for 6 weeks
Cohort 5 20 mg/kg I.V., once every 3 weeks for 6 weeks
ImClone Investigational Site
Indianapolis, Indiana, United States
ImClone Investigational Site
Durham, North Carolina, United States
ImClone Investigational Site
Philadelphia, Pennsylvania, United States
Number of participants with Adverse Events (AEs)
Time frame: 8 Weeks
Maximum Tolerated Dose
Time frame: 8 Weeks
Maximum concentration (Cmax), cohorts 1, 2, 3, 4, and 5
Time frame: 8 Weeks
Minimum concentration (Cmin), cohorts 1, 2, 3, 4, and 5
Time frame: 8 Weeks
Area under concentration (AUC), cohorts 1, 2, 3, 4, and 5
Time frame: 8 Weeks
Half-life (t 1/2), cohorts 1, 2, 3, 4, and 5
Time frame: 8 Weeks
Clearance (Cl) rate drug is completely removed, cohorts 1, 2, 3, 4, and 5
Time frame: 8 Weeks
Volume of distribution (Vss) at steady state, cohorts 1, 2, 3, 4, and 5
Time frame: 8 Weeks
Serum Anti-IMC-1121B Antibody Assessment (immunogenicity)
Time frame: 8 Weeks
Change in tumor size from Baseline Measurement
Time frame: 8 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.