RecruitingCancer Weight Loss

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

Eligible age

18+ yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

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About this study

This is a randomized, double-blind, placebo-controlled basket trial evaluating mifomelatide (TCMCB07) administered daily by subcutaneous (SC) injection in up to 120 patients. Patients will be enrolled into two cohorts 1) patients with newly diagnosed, advanced, unresectable colorectal cancer (CRC) or 2) patients with newly diagnosed, advanced, unresectable pancreatic ductal adenocarcinoma (PDAC). Within each cohort, patients will be randomized 1:1:1:1 to receive placebo or one of three different doses of mifomelatide (12.5 mg, 25 mg, or 50 mg). This study is designed to evaluate the effects of different doses of mifomelatide on weight, body composition and BMI. The double-blind (DB) phase will generally begin on the first day of 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. Upon completion of the DB treatment period, eligible patients may enroll in an optional Open Label Extension (OLE) phase and receive mifomelatide SC 25 mg daily for up to an additional 26 weeks. The purpose of the OLE is to further evaluate long-term safety, tolerability and efficacy of mifomelatide.

Sponsor: Endevica Bio

You may qualify if…

✓ 1. Must be at least 18 years of age.
✓ 2. An ECOG performance status of ≤ 2.
✓ 3. Life expectancy of ≥ 4 months.
✓ 4. Able to eat and digest food normally. Patients with colostomies are allowed.
✓ 5. Must meet the following:
✓ 1. Newly diagnosed colorectal adenocarcinoma (CRC) or pancreatic ductal adenocarcinoma (PDAC) that is unresectable, locally advanced (i.e., surgery with curative intent is not an option) or metastatic. Note: patients must not have relapsed within 6 months after completing prior treatment for early-stage disease.
✓ 2. Determined by the Investigator to be ready to receive their second dose of chemotherapy.
✓ 3. Patients currently enrolled and receiving study intervention under Protocol Version 2.0 may be eligible to enroll into Protocol Version 3.0, provided the amended protocol has received all regulatory and ethics approvals and the patient has reviewed and signed the updated consent form prior to any procedures conducted under the amended protocol. Enrollment into the OLE phase must occur ≤14 days following completion of the Week 12 DB visit.

You may not qualify if…

✕ 1. Patients receiving second line or later systemic treatment
✕ 2. Patients with swallowing abnormalities, malabsorption syndromes, short or inflammatory bowel syndromes, or other conditions that in the Investigator's opinion could impair food consumption or metabolism.
✕ 3. History of weight loss surgery including gastric stapling, or bypass surgery.
✕ 4. Currently using any new agent prescribed to increase appetite or otherwise affect weight (increase or decrease).
✕ a) Antiemetics or other standard of care medications for treatment or prevention of nausea and vomiting are acceptable.
✕ 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.