Safely Optimizing Body Weight With Mifomelatide (TCMCB07) in Patients With Newly Diagnosed Colorectal Cancer (CRC) or Pancreatic Ductal Adenocarcinoma (PDAC) Undergoing Chemotherapy
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Nowo rozpoznany rak jelita grubego lub trzustki, który nie może być operacyjnie usunięty
- •Przygotowanie do drugiej dawki chemioterapii
- •Zdolność do normalnego jedzenia i trawienia pokarmu
- •Spodziewana długość życia co najmniej 4 miesiące
- •Umiejętność samodzielnego podawania zastrzyków lub możliwość pomocy opiekuna
- •Prawidłowe wyniki badań krwi dotyczące liczby białych krwinek i płytek krwi
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 15, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (26)
Arizona Clinical Research Center
Tucson, United States
Cedars-Sinai Medical Center
Los Angeles, United States
UCLA Medical Center
Santa Monica, United States
Life Clinical Trials
Coral Springs, United States
Bioresearch Partners
Hialeah, United States
D&H Cancer Research Center
Margate, United States
Mt. Sinai Cancer Center
Miami Beach, United States
BRCR Global
Tamarac, United States
Piedmont Healthcare Inc.
Atlanta, United States
Northwestern University - Robert H. Lurie Comprehensive Cancer Center
Chicago, United States
Hope and Healing Cancer Services
Hinsdale, United States
Orchard Healthcare Research
Skokie, United States
Cancer Centers of Kansas
Wichita, United States
Karmanos Cancer Center
Detroit, United States
NHO Revive Research Institute
Lincoln, United States
Nebraska Cancer Specialists
Omaha, United States
NYU Langone Health Perlmutter Cancer Center
New York, United States
Duke University Medical Center
Durham, United States
Hightower Clinical
Oklahoma City, United States
Medical University of South Carolina
Charleston, United States
Baptist Clinical Research
Memphis, United States
Vanderbilt-Ingram Cancer Center
Nashville, United States
Lumi Research
Kingwood, United States
Laguna Clinical Research Associates
Laredo, United States
University of Virginia
Charlottesville, United States
Cross Cancer Institute
Edmonton, Canada
Trial contact
Daniel Marks, MD/PHD
Meghan Joly, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/16/2026.
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