Optimizing Body Mass Index (BMI) With TCMCB07, The Paradox Trial

Eligibility Criteria

• 1. Must be at least 18 years of age.
• 2. An ECOG performance status of ≤ 2.
• 3. Life expectancy of ≥ 9 months.
• 4. Able to eat and digest food normally. Patients with colostomies are allowed.
• 5. Must have newly diagnosed metastatic colorectal adenocarcinoma about to start first line chemotherapy.
• 6. Starting chemotherapy routines allowed are: FOLFOX, FOLFIRI, or FOLFIRINOX with or without bevacizumab, or other monoclonals or other FDA approved agents to be dosed every 2 weeks. The primary cancer therapy (dose, schedule, or drugs) may be changed as medically indicated.
• 7. Must have a BMI between 18 and ≤ 29 kg/m2.
• 8. Must be able and willing to safely self-inject daily or be injected by a care giver.
• 9. Must have measurable disease by RECIST 1.1 criteria.
• 10. Must have adequate end organ function as defined by:
• * Bone marrow function
• * ANC ≥ 1.5 × 109/L
• * Platelets ≥ 100 × 109/L
• * Hemoglobin ≥ 9 g/dL
• * Hepatic function
• * AST and ALT ≤ 3 × ULN; if liver metastases, then ≤ 5 × ULN
• * Bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome
• * Albumin between 3.4 and 5.4 gm/dL or within institutional normal limits
• * Renal function
• * Metabolic function o Normal hemoglobin A1c levels based on institutional normal limits
• 11. NT-Pro-BNP and Troponins (TnI, TnT) within institutional normal limits.
• 12. If a female of childbearing capacity, must have a negative pregnancy test within 2 weeks of starting treatment.
• 13. Fertile men and women must agree to use adequate contraception for the duration of the trial.
• 14. Willing and able to sign informed consent.
• 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.
• 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).
• * THC containing agents (e.g., dronabinol, cannabis) or other weight promoting agents including androgenic compounds (e.g., testosterone, oxandrolone), dopamine antagonists, or megestrol acetate within the past 6 months is excluded. Chronic (\> 6 months) use is allowed for THC.
• * 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 (\<4mg) 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 central nervous system (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).
• 15. Active infection with Hepatitis B, Hepatitis C, or active systemic viral disease or active severe infection. Patients with a history of HIV regardless of viral load are excluded.
• 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.