NCT06937177

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Endevica Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer Weight Loss

Interventions

Type	Name	Description
DRUG	TCMCB07	TCMCB07 is will be provided in single-use vials for subcutaneous administration
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2025-04-28
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2025-04-22
• Last updated: 2025-12-12

Locations

17 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study