Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

This is a randomized, double-blind, placebo-controlled study of B07, administered daily by subcutaneous (SC) injection, in up to 100 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 (18 to ≤ 29 kg/m2). Treatment will begin on the same day as the start of cancer chemotherapy and continue during the first 28 days of cytotoxic therapy with a goal of preserving muscle and fat mass, relative to placebo control.

Official Title

Optimizing Body Mass Index (BMI) With TCMCB07 in Patients With Newly Diagnosed Metastatic Colorectal Cancer Undergoing Chemotherapy

Keywords

Cachexia; Cancer, Metastatic colorectal cancer, Colorectal carcinoma, BMI, Cachexia, TCMCB07

Eligibility

Locations

  • Investigative Site not yet accepting patients
    Los Angeles California 90095 United States
  • Investigative Site not yet accepting patients
    Los Angeles California 90048 United States
  • Investigative Site accepting new patients
    Hialeah Florida 33013 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Endevica Bio
ID
NCT06937177
Phase
Phase 2 Colorectal Cancer Research Study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated