Safely Optimizing Body Weight With Mifomelatide (TCMCB07) in Patients With Newly Diagnosed Colorectal Cancer (CRC) or Pancreatic Ductal Adenocarcinoma (PDAC) Undergoing Chemotherapy
Public ClinicalTrials.gov record NCT06937177. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06937177
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 27, 2025
- Primary completion
- Sep 30, 2027
- Completion
- Nov 30, 2027
- Last update posted
- Jul 14, 2026
2025 – 2027
United States locations
- U.S. sites
- 25
- U.S. states
- 15
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Clinical Research Center | Tucson | Arizona | 85715 | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Recruiting |
| UCLA Medical Center | Santa Monica | California | 90404 | Recruiting |
| Life Clinical Trials | Coral Springs | Florida | 33071 | Recruiting |
| Bioresearch Partners | Hialeah | Florida | 33013 | Recruiting |
| D&H Cancer Research Center | Margate | Florida | 33063 | Recruiting |
| Mt. Sinai Cancer Center | Miami Beach | Florida | 33140 | Recruiting |
| BRCR Global | Tamarac | Florida | 33321 | Recruiting |
| Piedmont Healthcare Inc. | Atlanta | Georgia | 30318 | Recruiting |
| Northwestern University - Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 60611 | Not yet recruiting |
| Hope and Healing Cancer Services | Hinsdale | Illinois | 60521 | Not yet recruiting |
| Orchard Healthcare Research | Skokie | Illinois | 60077 | Recruiting |
| Cancer Centers of Kansas | Wichita | Kansas | 67214 | Recruiting |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | Recruiting |
| NHO Revive Research Institute | Lincoln | Nebraska | 68506 | Recruiting |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | Recruiting |
| NYU Langone Health Perlmutter Cancer Center | New York | New York | 10016 | Recruiting |
| Duke University Medical Center | Durham | North Carolina | 27710 | Recruiting |
| Hightower Clinical | Oklahoma City | Oklahoma | 73102 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Not yet recruiting |
| Baptist Clinical Research | Memphis | Tennessee | 38120 | Recruiting |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | Not yet recruiting |
| Lumi Research | Kingwood | Texas | 77090 | Recruiting |
| Laguna Clinical Research Associates | Laredo | Texas | 78041 | Recruiting |
| University of Virginia | Charlottesville | Virginia | 22908 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06937177, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06937177 live on ClinicalTrials.gov.