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

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

Trial Details

NCT ID
NCT06937177
Phase
PHASE2
Sponsor
Endevica Bio
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • TCMCB07
  • Placebo
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Los Angeles, California, United States|34.05223,-118.24368
  • Santa Monica, California, United States|34.01949,-118.49138
  • Coral Springs, Florida, United States|26.27119,-80.2706
  • Hialeah, Florida, United States|25.8576,-80.27811

Key Eligibility Criteria

  • Must be at least 18 years of age.
  • An ECOG performance status of ≤ 2.
  • Life expectancy of ≥ 4 months.
  • Able to eat and digest food normally. Patients with colostomies are allowed.

For full eligibility, visit ClinicalTrials.gov.

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