Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Colorectal Cancer Undergoing Chemotherapy
This is a randomized, double-blind, placebo-controlled study of B07, administered daily by subcutaneous (SC) injection, in up to 120 patients with newly diagnosed locally advanced, unresectable or metastatic colorectal cancer. This study will evaluate different doses of B07 on weight, body composition and BMI in patients with sub-optimal BMIs (≤ 29 kg/m\^2). Treatment will start at the second cycle of first-line cancer chemotherapy and continue for 12-weeks with the goal of maintaining body weight and muscle mass in patients undergoing chemotherapy relative to control.
• 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 or unresectable, locally advanced (i.e., surgery with curative intent is. not an option) colorectal adenocarcinoma and about to start first line chemotherapy. Patients must not have relapsed within 6 months after completing prior treatment for early-stage disease.
‣ 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 evaluable disease by RECIST 1.1.
⁃ 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.