Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Metastatic Colorectal Cancer Undergoing Chemotherapy

Exclusion Criteria

• •1. Patients receiving second line or later systemic treatment for stage IV disease.
• •2. Patients with swallowing abnormalities, malabsorption syndromes, short or inflammatory bowel syndromes, or other conditions that in the Investigator's opinion could impair food consumption or metabolism.
• •3. History of weight loss surgery including gastric stapling, or bypass surgery.
• •4. Unintentional weight loss ≥ 10% of usual body weight in 4 months prior to Screening or other weight loss considered significant by the Investigator.
• •5. Currently using any new agent designed to increase appetite or otherwise affect weight (increase or decrease).
• •1. THC containing agents (e.g., dronabinol, cannabis). Chronic (\> 6 months) use is allowed for THC.
• •2. Other weight promoting agents including androgenic compounds (e.g., testosterone, oxandrolone), dopamine antagonists, or megestrol acetate within the past 6 months is excluded.
• •3. Newly prescribed glucocorticoids for less than four weeks at the time of Screening and whose weight is not yet stable are excluded. Stable (dose unchanged for 4 weeks or more) and low dose (\<4 mg) corticosteroids are permissible, as are inhaled corticosteroids.
• •6. Chronic and ongoing use of corticosteroids at a dose of ≥5 mg of prednisone or equivalent per day.
• •7. History of bulimia or anorexia.
• •8. Pregnancy, lactation, or plans to become pregnant.
• •9. History of another malignancy except basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy that has previously undergone potentially curative therapy.
• •10. Concurrent participation in any other clinical trial.
• •11. Patients with known brain or CNS metastases.
• •12. Impaired cardiac function or significant cardiac issues including, but not limited to, any of the following:
• •1. Greater than class II NYHA congestive heart failure
• •2. Congenital long QT syndrome
• •3. QTc \> 470 msec (as calculated by institution standards) confirmed by two ECGs ≥ 1-minute apart (interval corrected using \[Bazett's formula \[QTcB\])
• •4. Unstable angina pectoris
• •5. Acute myocardial infarction ≤ 6 months prior to study entry
• •13. Known hypersensitivity to B07 or its formulation.
• •14. Known diagnosis of HIV infection (HIV testing is not mandatory). Patients with a history of HIV regardless of viral load are excluded.
• •15. Active infection with Hepatitis B, Hepatitis C, or active systemic viral disease or active severe infection.
• •16. Unwilling or unable to comply with the protocol.
• •17. Any condition that, in the Investigator's opinion, would impair the patients' ability to participate in this study.