NCT06937177 · Endevica Bio
Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Metastatic Colorectal Cancer Undergoing Chemotherapy
What this study is about
This is a randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment study of B07, administered daily by injected under the skin (SC) injection, in up to 120 patients with newly diagnosed metastatic colorectal cancer.
View original scientific description
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).
Interventions
DRUG
TCMCB07
TCMCB07 is will be provided in single-use vials for subcutaneous administration
DRUG
Placebo
Matching placebo
Primary outcome measures
Change from baseline in body weight
Time frame: At 12 weeks of treatment
Incidence and severity of adverse events (AEs), AESIs, and SAEs
Time frame: From enrollment to the end of the 12 week dosing period
Incidence of abnormalities in laboratory evaluations
Time frame: From enrollment to the end of the 12 week dosing period
Incidence of abnormalities in vital signs
Time frame: From enrollment to the end of the 12 week dosing period
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 dosed every 2 weeks. The primary cancer therapy (dose, schedule, or drugs) may be changed as medically indicated. 7. Must have a BMI ≤ 29 kg/m\^2. 8. Must be able and willing to safely self-inject daily or be injected by a caregiver. 9. Must have measurable disease by RECIST 1.1 criteria. 10. Must have adequate end organ function as defined by: 1. ANC ≥ 1.5 × 10\^9/L 2. Platelets ≥ 100 ×
Where
- Tucson, Arizona
- Los Angeles, California
- Santa Monica, California
- Coral Springs, Florida
- Hialeah, Florida
- Margate, Florida
- Miami Beach, Florida
- Tamarac, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Hinsdale, Illinois
- Skokie, Illinois
And 13 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations