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RECRUITING
NCT06937177
PHASE2

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

Sponsor: Endevica Bio

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-04-28

Completion Date

2026-09

Last Updated

2025-12-12

Healthy Volunteers

No

Interventions

DRUG

TCMCB07

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

DRUG

Placebo

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