This clinical trial is about testing GO-203-2c, which is a newly discovered compound that binds to an oncoprotein (a cancer causing protein) called MUC1 (which is over-expressed in many cancers). By binding to MUC1, GO-203-2c eventually causes tumor cell death in laboratory studies. This study is being done to: * Test the safety of GO-203-2c and see what effects (good and bad) it has on you and your cancer * Find the highest dose of GO-203-2c that can be given without causing bad side effects * Examine how much GO-203-2c is in the blood at certain times after it is given and how quickly the body gets rid of it * Observe whether there is any effect of GO-203-2c on the size and activity of cancer in your body
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
GO-203-2c Injection is a non-preserved, sterile, ready-to-use liquid dosage form provided in a glass vial with rubber closure and crimp seal. Injection will be added to the contents of an intravenous bag (of 0.9% NS, D5W or sterile water) to a final concentration of between 0.03 - 0.3 mg/ml (preferable in 100 mls or greater) and administered as a single agent intravenously over 60 minutes. A treatment cycle will consist of a daily IV dose administered for 21 consecutive days followed by a 7 day rest.
TGen Clinical Research Service
Scottsdale, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
To determine the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) of GO-203-2c - To establish the dose of GO-203-2c recommended for future phase II protocols
Time frame: 24 months
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