Condition: Cancer Weight Loss · Sponsor: Endevica Bio
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.
This description comes directly from the study's public registry record.
Daniel Marks, MD/PHD · 503-754-5624 · dan@endevicabio.com
Meghan Joly, PhD · Meghan@endevicabio.com
Always discuss trial participation with your own doctor first.
| Arizona Clinical Research Center | Tucson, Arizona, United States | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles, California, United States | Recruiting |
| UCLA Medical Center | Santa Monica, California, United States | Recruiting |
| Life Clinical Trials | Coral Springs, Florida, United States | Recruiting |
| Bioresearch Partners | Hialeah, Florida, United States | Recruiting |
| D&H Cancer Research Center | Margate, Florida, United States | Recruiting |
| Mt. Sinai Cancer Center | Miami Beach, Florida, United States | Recruiting |
| BRCR Global | Tamarac, Florida, United States | Recruiting |
| Piedmont Healthcare Inc. | Atlanta, Georgia, United States | Recruiting |
| Northwestern University - Robert H. Lurie Comprehensive Cancer Center | Chicago, Illinois, United States | Not Yet Recruiting |
| Hope and Healing Cancer Services | Hinsdale, Illinois, United States | Not Yet Recruiting |
| Orchard Healthcare Research | Skokie, Illinois, United States | Recruiting |
+ 14 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06937177