TCMCB07 for Cachexia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called TCMCB07 for cachexia, a condition causing significant weight and muscle loss in patients with newly diagnosed metastatic colorectal cancer. The goal is to determine if different doses of TCMCB07 can maintain body weight and muscle mass during chemotherapy. Participants will receive daily injections for 12 weeks and will be compared to those receiving a placebo (a non-active treatment). This trial may suit individuals with a BMI of 29 or less who are about to start their second cycle of chemotherapy for metastatic colorectal cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications. However, you cannot use new agents designed to affect weight, certain THC agents, or high-dose corticosteroids. Stable, low-dose corticosteroids are allowed.
Is there any evidence suggesting that TCMCB07 is likely to be safe for humans?
Research has shown that TCMCB07 is generally safe. In earlier human studies, safety was a primary focus, and participants tolerated the treatment well, reporting no serious adverse reactions. In animal studies, TCMCB07 addressed issues like appetite loss and weight stability without causing harm. In dogs, both low and high doses proved safe, with no major side effects observed. This evidence suggests that TCMCB07 might be a safe option for humans based on these earlier findings.12345
Why do researchers think this study treatment might be promising for cachexia?
Researchers are excited about TCMCB07 for treating cachexia because it offers a new approach compared to existing treatments like appetite stimulants and corticosteroids. Unlike these standard options, TCMCB07 is administered subcutaneously, which might improve patient compliance and effectiveness. Additionally, TCMCB07 has a unique mechanism of action that targets the underlying metabolic issues in cachexia rather than just alleviating symptoms. This potential to directly address the metabolic imbalance could lead to more significant improvements in patients' quality of life.
What evidence suggests that TCMCB07 might be an effective treatment for cachexia?
Research has shown that TCMCB07 might help treat cachexia, a condition causing weight and muscle loss in cancer patients. Studies indicate that administering TCMCB07 outside the brain can boost appetite, stabilize body weight, and maintain muscle mass. In animal studies, it reduced cachexia symptoms linked to cancer and other diseases, such as chronic kidney disease. Reports from individuals who have taken TCMCB07 suggest it improves appetite and helps maintain weight. This treatment works by blocking a specific receptor in the body that controls hunger and energy use. Participants in this trial will receive different dosages of TCMCB07 or a placebo to evaluate its effectiveness and safety.14678
Are You a Good Fit for This Trial?
This trial is for up to 100 patients with newly diagnosed metastatic colorectal cancer who have a BMI between 18 and ≤29 kg/m2. Participants will receive treatment alongside their first round of chemotherapy, aiming to preserve muscle and fat mass.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TCMCB07 or placebo daily by subcutaneous injection during the first 28 days of chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TCMCB07
Find a Clinic Near You
Who Is Running the Clinical Trial?
Endevica Bio
Lead Sponsor