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Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma

Conditions

Malignant Melanoma | Melanoma

What is the purpose of this trial?

The purpose of this research study is to see if the study drug, CT-011, is safe to give and if it helps people with melanoma that has spread to other areas of their body. CT-011 is a monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Monoclonal antibodies are antibodies made in a lab instead of by the immune system which then recruit the immune system to help fight cancer cells.

All final eligible subjects will receive an intravenous infusion of CT-011. This study will test two dose levels of the study drug:

Group 1: Patients in this group will be given the study drug at dose level 1 (1.5 mg/kg).

Group 2: Patients in this group will be given the study drug at dose level 2 (6.0 mg/kg).

Each group will be given the study drug through an IV (a needle put into a vein in the arm) on day 1. After day 1, the study drug will be given every other week. Patients may be given a total of up to 27 study drug infusions for about 12 months while they are in the study. Approximately 100 patients will participate in this study.



Participation Guidelines

Age:
18 Years and older
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
CureTech Ltd
Dates:
November 2011
Last Updated:
May 30, 2012
Study HIC#:
1109008992

Clinicaltrials.gov ID: NCT01435369