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

Conditions

• Cancer Weight Loss

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TCMCB07 — DRUG
  TCMCB07 is will be provided in single-use vials for subcutaneous administration
• Placebo — DRUG
  Matching placebo

Study Details

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.

Key Dates

First listed

Apr 22, 2025

Start date

Apr 28, 2025

Status verified

Jul 2026

Primary completion

Oct 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo administered subcutaneously daily for 12 weeks
• Experimental: Mifomelatide (TCMCB07) 12.5 mg administered subcutaneously daily for 12 weeks
• Experimental: Mifomelatide (TCMCB07) 25 mg administered subcutaneously daily for 12 weeks
• Experimental: Mifomelatide (TCMCB07) 50 mg administered subcutaneously daily for 12 weeks

Primary Outcome Measure

Change from baseline in body weight [ Time Frame: At 12 weeks of treatment ]

Central Contacts

• Daniel Marks, MD/PHD
  503-754-5624
  [email protected]
• Meghan Joly, PhD
  [email protected]

Locations (25)

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