Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Colorectal Cancer Und… (NCT06937177) | Clinical Trial Compass
RecruitingPhase 2
Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Colorectal Cancer Undergoing Chemotherapy
United States120 participantsStarted 2025-04-28
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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.
Exclusion criteria
What they're measuring
1
Change from baseline in body weight
Timeframe: At 12 weeks of treatment
2
Incidence and severity of adverse events (AEs)
Timeframe: From enrollment to the end of the 12 week dosing period
3
Incidence of abnormalities in laboratory evaluations
Timeframe: From enrollment to the end of the 12 week dosing period
4
Incidence of abnormalities in vital signs
Timeframe: From enrollment to the end of the 12 week dosing period
. 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). Antiemetics for control of nausea and vomiting are acceptable.
✕. 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.