RecruitingPhase 2NCT06937177

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


Sponsor

Endevica Bio

Enrollment

120 participants

Start Date

Apr 28, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called TCMCB07 can help newly diagnosed metastatic colorectal cancer patients maintain a healthy body weight while undergoing chemotherapy. Cancer-related weight loss is a serious problem that can make treatment harder. Researchers hope this drug can safely preserve body weight and muscle mass. **You may be eligible if...** - You are 18 or older with newly diagnosed metastatic colorectal cancer and are about to start first-line chemotherapy - Your performance level is good enough to carry out daily activities with minimal limitations - Your BMI is 29 or below (not overweight/obese) - You are able to eat normally and self-inject the study drug daily - Your life expectancy is at least 9 months **You may NOT be eligible if...** - You have previously received chemotherapy for metastatic colorectal cancer - You have significant organ dysfunction - You are unable to self-inject or have a caregiver who can inject for you - You have conditions that affect your ability to eat or digest food normally Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTCMCB07

TCMCB07 is will be provided in single-use vials for subcutaneous administration

DRUGPlacebo

Matching placebo


Locations(17)

Investigative Site

Tucson, Arizona, United States

Investigative Site

Los Angeles, California, United States

Investigative Site

Los Angeles, California, United States

Investigative Site

Hialeah, Florida, United States

Investigative Site

Margate, Florida, United States

Investigative Site

Miami Beach, Florida, United States

Investigative Site

Tamarac, Florida, United States

Investigative Site

Atlanta, Georgia, United States

Investigative Site

Wichita, Kansas, United States

Investigative Site

Detroit, Michigan, United States

Investigative Site

Lincoln, Nebraska, United States

Investigative Site

Omaha, Nebraska, United States

Investigative Site

Durham, North Carolina, United States

Investigative Site

Oklahoma City, Oklahoma, United States

Investigative Site

Kingwood, Texas, United States

Investigative Site

Laredo, Texas, United States

Investigative Site

Edmonton, Alberta, Canada

View Full Details on ClinicalTrials.gov

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NCT06937177