Clinical Trials | Optimizing Body Mass Index (BMI) with TCMCB07 in Patients with Newly Diagnosed Metastatic Colorectal Cancer Undergoing Chemotherapy

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with newly diagnosed Metastatic Colorectal Cancer undergoing chemotherapy. The purpose of this study is to evaluate the safety of an investigational drug, called B07, and what effects it will have on your weight over time. The study drug, B07, is a new investigational treatment that may help patients with cancer gain and/or maintain their weight. Cancer patients who weigh more and therefore who have a higher body mass index (BMI) tend to live longer than those with a lower BMI. The study drug is considered investigational because it has not been approved for sale by the United States Food and Drug Administration (FDA). This study includes the use of a placebo (dummy inactive compound). This study is considered a double-blind study because neither you or your study doctor will know whether you are getting B07 or placebo. The decision on whether you receive placebo or B07, including how much B07, is done by chance (like flipping a coin) and will be kept secret. Making this decision is called “randomization”. It is a part of clinical studies that makes the final results more reliable. In this study, there is a 75% chance of receiving the active study drug B07. The study involves receiving the investigational drug daily, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as being weighed, having your blood drawn, imaging, and talking to the study doctor. If you choose to participate the study will consist of three parts: screening, study treatment, and follow-up. The screening period is where the study team will see if you are eligible for the study. After screening, if you are deemed eligible for participation, you will enter the treatment period and you will be given either the experimental weight gain/maintenance drug called B07 or placebo for 28-days (4 weeks) in addition to approved drugs considered “standard of care” for treating advanced colorectal cancer. After the 28 days of treatment, you will have an end of treatment visit and a follow-up visit with the study team. Your participation will last approximately 11 weeks total. The study drugs, B07 or placebo, will be provided by the sponsor at no cost to you. All additional study procedures that are beyond your standard medical care, including laboratory tests, physical examinations, and visits to the study center, are provided to you at no charge. Additional information can be found here: https://clinicaltrials.gov/study/NCT06937177 [email protected]