Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Metastatic Colorectal Cancer Undergoing Chemotherapy
Endevica Bio
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Must be at least 18 years of age. 2. An ECOG performance status of ≤ 2. 3. Life expectancy of ≥ 9 months. 4. Able to eat and digest food normally. Patients with colostomies are allowed. 5. Must meet the following: 1. Newly diagnosed metastatic colorectal adenocarcinoma and about to start first line chemotherapy. 2. Determined by the Investigator to be ready to receive their second dose of chemotherapy. 6. Starting chemotherapy routines allowed are: FOLFOX, FOLFIRI, or FOLFIRINOX with or without bevacizumab, or other monoclonals or other FDA approved agents to be…
Interventions
- DrugTCMCB07
TCMCB07 is will be provided in single-use vials for subcutaneous administration
- DrugPlacebo
Matching placebo
Locations (17)
- Investigative SiteTucson, Arizona
- Investigative SiteLos Angeles, California
- Investigative SiteLos Angeles, California
- Investigative SiteHialeah, Florida
- Investigative SiteMargate, Florida
- Investigative SiteMiami Beach, Florida