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Mifomelatide for Weight Management in Colorectal or Pancreatic Cancer

This study is testing a drug called mifomelatide (TCMCB07) to see if it can help patients with newly diagnosed colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC) maintain a healthy body weight while undergoing chemotherapy. You could be eligible if you are at least 18 years old, have one of these cancers that is advanced or unresectable (cannot be removed by surgery), and have a life expectancy of at least 4 months. The main goals are to see how much your body weight changes over 12 weeks and to track any side effects or changes in lab tests. The study status is currently unclear, and it plans to enroll up to 120 patients.

Study design
This is a randomized, double-blind, placebo-controlled study involving up to 120 participants. Participants will receive either mifomelatide at one of three different doses or a placebo.
What's involved
You would receive daily injections of the study drug or placebo for 12 weeks. Your body weight, side effects, and lab tests will be monitored during this period.
Compensation
Not stated in the trial record.
Follow-up
Your safety and lab results will be monitored from enrollment until the end of the 12-week dosing period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06937177

Safely Optimizing Body Weight With Mifomelatide (TCMCB07) in Patients With Newly Diagnosed Colorectal Cancer (CRC) or Pancreatic Ductal Adenocarcinoma (PDAC) Undergoing Chemotherapy

Recruiting
PHASE2Ages 18+InterventionalTreatment
Endevica Bio
~120 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:TCMCB07Placebo

At a glance

Recruiting sites
22 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in body weight
Measured over At 12 weeks of treatment
+3 more outcomes measured

Conditions

Cancer Weight Loss

Explore related trials

Colorectal CarcinomaPancreatic Ductal Adenocarcinoma

Where it's being run

26 sites across 16 states
Florida5
Illinois3
California2
Nebraska2
Tennessee2
Texas2
Arizona1
Georgia1

Who to contact

Daniel Marks, MD/PHD
[email protected]
503-754-5624
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Patients with newly prescribed glucocorticoids for less than four weeks at the time of Screening and whose weight is not yet stable are excluded. Stable (dose unchanged for 4 weeks or more) and low dose (\<5 mg) corticosteroids are permissible, as are inhaled corticosteroids.
Drugs like Olanzapine are allowed only when used as an antiemetic, as needed (PRN). If used to treat cachexia, drugs like Olanzapine are not allowed. 5. Chronic and ongoing use of corticosteroids at a dose of ≥5 mg of prednisone or equivalent per day. 6. History of bulimia or anorexia. 7. Pregnancy, lactation, or plans to become pregnant. 8. History of another malignancy except basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy that has previously undergone potentially curative therapy. 9. Concurrent participation in any other clinical trial. 10. Patients with known brain or CNS metastases. 11. Impaired cardiac function or significant cardiac issues including, but not limited to, any of the following:

What this trial measures

  • Change from baseline in body weightAt 12 weeks of treatment
  • Incidence and severity of adverse events (AEs), AESIs, and SAEsFrom enrollment to the end of the 12 week dosing period
  • Incidence of abnormalities in laboratory evaluationsFrom enrollment to the end of the 12 week dosing period
  • Incidence of abnormalities in vital signsFrom enrollment to the end of the 12 week dosing period