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

Inclusion 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 firstline chemotherapy.

6. Starting chemotherapy routines allowed are: FOLFOX, FOLFIRI, or FOLFIRINOX with orwithout bevacizumab, or other monoclonals or other FDA approved agents to be dosedevery 2 weeks. The primary cancer therapy (dose, schedule, or drugs) may be changedas 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'sSyndrome

• Albumin between 3.4 and 5.4 gm/dL or within institutional normal limits

• Renal functiono Creatinine clearance ≥ 50 mL/min (calculated by Cockcroft and Gault equationSee Appendix 2 [Section 10.2]).

• Metabolic function o Normal hemoglobin A1c levels based on institutional normallimits

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 2weeks of starting treatment.

13. Fertile men and women must agree to use adequate contraception for the duration ofthe trial.

14. Willing and able to sign informed consent.

Exclusion Criteria:

1. Patients receiving second line or later systemic treatment for stage IV disease.

2. Patients with swallowing abnormalities, malabsorption syndromes, short orinflammatory bowel syndromes, or other conditions that in the Investigator's opinioncould 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 Screeningor other weight loss considered significant by the Investigator.

5. Currently using any new agent designed to increase appetite or otherwise affectweight (increase or decrease).

• THC containing agents (e.g., dronabinol, cannabis) or other weight promotingagents including androgenic compounds (e.g., testosterone, oxandrolone),dopamine antagonists, or megestrol acetate within the past 6 months isexcluded. Chronic (> 6 months) use is allowed for THC.

• Newly prescribed glucocorticoids for less than four weeks at the time ofScreening and whose weight is not yet stable are excluded. Stable (doseunchanged for 4 weeks or more) and low dose (<4mg) corticosteroids arepermissible, as are inhaled corticosteroids.

6. Chronic and ongoing use of corticosteroids at a dose of ≥5 mg of prednisone orequivalent 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 insitu of the cervix or other noninvasive or indolent malignancy that has previouslyundergone 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 limitedto, any of the following:

13. Greater than class II NYHA congestive heart failure

14. Congenital long QT syndrome

15. QTc > 470 msec (as calculated by institution standards) confirmed by two ECGs ≥ 1-minute apart (interval corrected using [Bazett's formula [QTcB])

16. Unstable angina pectoris

17. Acute myocardial infarction ≤ 6 months prior to study entry

18. Known hypersensitivity to B07 or its formulation.

19. Known diagnosis of HIV infection (HIV testing is not mandatory).

20. Active infection with Hepatitis B, Hepatitis C, or active systemic viral disease oractive severe infection. Patients with a history of HIV regardless of viral load areexcluded.

21. Unwilling or unable to comply with the protocol.

22. Any condition that, in the Investigator's opinion, would impair the patients'ability to participate in this study.