Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Metastatic 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 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.

Trial Details

NCT ID
NCT06937177
Phase
PHASE2
Sponsor
Endevica Bio
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • TCMCB07
  • Placebo
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Hialeah, Florida, United States|25.8576,-80.27811
  • Margate, Florida, United States|26.24453,-80.20644

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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