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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
TCMCB07 is will be provided in single-use vials for subcutaneous administration
Matching placebo
Investigative Site
Tucson, Arizona, United States
RECRUITINGInvestigative Site
Los Angeles, California, United States
RECRUITINGInvestigative Site
Los Angeles, California, United States
RECRUITINGInvestigative site
Coral Springs, Florida, United States
RECRUITINGInvestigative Site
Hialeah, Florida, United States
RECRUITINGInvestigative Site
Margate, Florida, United States
RECRUITINGInvestigative Site
Miami Beach, Florida, United States
RECRUITINGInvestigative Site
Tamarac, Florida, United States
RECRUITINGInvestigative Site
Atlanta, Georgia, United States
RECRUITINGInvestigative Site
Chicago, Illinois, United States
NOT_YET_RECRUITING...and 16 more locations
Change from baseline in body weight
Time frame: At 12 weeks of treatment
Incidence and severity of adverse events (AEs)
Time frame: From enrollment to the end of the 12 week dosing period
Incidence of abnormalities in laboratory evaluations
Time frame: From enrollment to the end of the 12 week dosing period
Incidence of abnormalities in vital signs
Time frame: From enrollment to the end of the 12 week dosing period
Change from baseline in total score of Functional Assessment of Anorexia/Cachexia Therapy-anorexia-related symptoms scale (FAACT-5IASS)
FAACT-5IASS scores items using a 5-point scale (0-4).Higher scores are associated with a higher health-related quality of life.
Time frame: At 12 weeks of treatment
Change from baseline in the anorexia and cachexia subscore of the Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS) questionnaire
FAACT-ACS score sums 12 items; both use a 5-point scale (0-4).Higher scores are associated with a higher health-related quality of life.
Time frame: At 12 weeks of treatment
Change from baseline in BMI
Weight and height will be combined to report BMI in kg/m\^2
Time frame: At 12 weeks of treatment
Change from baseline in body weight
Time frame: At 8 weeks of treatment
Change from baseline in BMI
Weight and height will be combined to report BMI in kg/m\^2
Time frame: At 8 weeks of treatment
Change from baseline in body weight
Time frame: At 4 weeks of treatment
Change from baseline in BMI
Weight and height will be combined to report BMI in kg/m\^2
Time frame: At 4 weeks of treatment
Change from baseline in the FAACT questionnaire comprising the general quality of life FAACT-G and FAACT-ACS anorexia and cachexia related subscale
FAACTG and FAACT ACS score score items using a 5-point scale (0-4).Higher scores are associated with a higher health-related quality of life.
Time frame: At 12 weeks of treatment
Change from baseline in total score and subscores of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Scoring ranges from 0 to 100 with 0 being the worst possible score and 100 being the best.
Time frame: At 12 weeks of treatment
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