OncoMatch/Clinical Trials/NCT06937177
Safely Optimizing Body Weight With Mifomelatide (TCMCB07) in Patients With Newly Diagnosed Colorectal Cancer (CRC) or Pancreatic Ductal Adenocarcinoma (PDAC) Undergoing Chemotherapy
Is NCT06937177 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies TCMCB07 for cancer weight loss.
Treatment: TCMCB07 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Pancreatic Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy (second line or later)
Patients receiving second line or later systemic treatment
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L or adequate as determined by investigator; Hemoglobin ≥ 9 g/dL or adequate as determined by investigator
Kidney function
Creatinine clearance ≥ 50 mL/min (Cockcroft and Gault equation)
Liver function
AST and ALT ≤ 3 × ULN; if liver metastases, then ≤ 5 × ULN; Bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome
Cardiac function
NT-Pro-BNP and Troponin (TnI or TnT) within normal limits or not clinically significant; Greater than class II NYHA congestive heart failure, congenital long QT syndrome, QTc > 470 msec, unstable angina pectoris, acute myocardial infarction ≤ 6 months prior to study entry [excluded]
Must have adequate end organ function as defined by: ANC ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Hemoglobin ≥ 9 g/dL; AST and ALT ≤ 3 × ULN; if liver metastases, then ≤ 5 ×ULN; Bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome; Albumin between 3.4 and 5.4 gm/dL or within institutional normal limits; Creatinine clearance ≥ 50 mL/min; Normal hemoglobin A1c levels; NT-Pro-BNP and Troponin (TnI or TnT) are within normal limits or not considered to be clinically significant by the investigator
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Arizona Clinical Research Center · Tucson, Arizona
- Cedars-Sinai Medical Center · Los Angeles, California
- UCLA Medical Center · Santa Monica, California
- Life Clinical Trials · Coral Springs, Florida
- Bioresearch Partners · Hialeah, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06937177 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy (second line or later) disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages