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

Inclusion Criteria

• Must be at least 18 years of age.
• An ECOG performance status of ≤ 2.
• Life expectancy of ≥ 9 months.
• Able to eat and digest food normally. Patients with colostomies are allowed.
• Must meet the following:
• Newly diagnosed metastatic colorectal adenocarcinoma and about to start first line chemotherapy.
• Determined by the Investigator to be ready to receive their second dose of chemotherapy.
• 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.
• Must have a BMI ≤ 29 kg/m^2.
• Must be able and willing to safely self-inject daily or be injected by a caregiver.
• Must have measurable disease by RECIST 1.1 criteria.
• Must have adequate end organ function as defined by:
• ANC ≥ 1.5 × 10^9/L
• Platelets ≥ 100 × 10^9/L, or adequate as determined by the medical judgement of the investigator
• Hemoglobin ≥ 9 g/dL, or adequate as determined by the medical judgement of the investigator
• 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, or not considered clinically significant by the investigator
• Creatinine clearance ≥ 50 mL/min (calculated by Cockcroft and Gault equation
• Normal hemoglobin A1c levels based on institutional normal limits, or not considered clinically significant by the investigator
• NT-Pro-BNP and Troponin (TnI or TnT) are within normal limits or not considered to be clinically significant by the investigator.
• If a female of childbearing capability, must have a negative pregnancy test within 2 weeks of starting treatment.
• Fertile men and women must agree to use adequate contraception for the duration of the trial.
• Willing and able to sign informed consent.

Exclusion Criteria

• Patients receiving second line or later systemic treatment for stage IV disease.
• 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.
• History of weight loss surgery including gastric stapling, or bypass surgery.
• Unintentional weight loss ≥ 10% of usual body weight in 4 months prior to Screening or other weight loss considered significant by the Investigator.
• Currently using any new agent designed to increase appetite or otherwise affect weight (increase or decrease).
• THC containing agents (e.g., dronabinol, cannabis). Chronic (> 6 months) use is allowed for THC.
• Other weight promoting agents including androgenic compounds (e.g., testosterone, oxandrolone), dopamine antagonists, or megestrol acetate within the past 6 months is excluded.
• 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.
• Chronic and ongoing use of corticosteroids at a dose of ≥5 mg of prednisone or equivalent per day.
• History of bulimia or anorexia.
• Pregnancy, lactation, or plans to become pregnant.
• 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.
• Concurrent participation in any other clinical trial.
• Patients with known brain or CNS metastases.
• Impaired cardiac function or significant cardiac issues including, but not limited to, any of the following:
• Greater than class II NYHA congestive heart failure
• Congenital long QT syndrome
• QTc > 470 msec (as calculated by institution standards) confirmed by two ECGs ≥ 1-minute apart (interval corrected using [Bazett's formula [QTcB])
• Unstable angina pectoris
• Acute myocardial infarction ≤ 6 months prior to study entry
• Known hypersensitivity to B07 or its formulation.
• Known diagnosis of HIV infection (HIV testing is not mandatory). Patients with a history of HIV regardless of viral load are excluded.
• Active infection with Hepatitis B, Hepatitis C, or active systemic viral disease or active severe infection.
• Unwilling or unable to comply with the protocol.
• Any condition that, in the Investigator's opinion, would impair the patients' ability to participate in this study.