Cancer Weight Loss study: TCMCB07
Official title Safely Optimizing Body Weight With Mifomelatide (TCMCB07) in Patients With Newly Diagnosed Colorectal Cancer (CRC) or Pancreatic Ductal Adenocarcinoma (PDAC) Undergoing Chemotherapy
ClinicalTrials.gov ID: NCT06937177
What this study is testing
What is TCMCB07?
TCMCB07 is an investigational daily injectable medicine being studied to help maintain weight and muscle mass in patients with advanced colorectal or pancreatic cancer.
Also referred to as mifomelatide.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if mifomelatide can help maintain body weight and muscle mass during chemotherapy. It also checks which dose is safest and most effective.
- Who it's for
- The study is looking for adults with newly diagnosed, advanced colorectal or pancreatic cancer who are starting their first round of chemotherapy.
- What's involved
- Participants will receive a daily injection under the skin of either mifomelatide or a placebo. They will have regular check-ups to monitor their weight, body composition, and any side effects.
- Time commitment
- The main part of the study lasts 12 weeks, with an optional extension of up to 26 more weeks for those who choose to continue.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- Newly diagnosed colorectal adenocarcinoma (CRC) or pancreatic ductal adenocarcinoma (PDAC) that is unresectable, locally advanced (i.e., surgery with...
You likely can't join if
- Patients receiving second line or later systemic treatment
- Patients with swallowing abnormalities, malabsorption syndromes, short or inflammatory bowel syndromes, or other conditions that in the...
- History of weight loss surgery including gastric stapling, or bypass surgery.
- Currently using any new agent prescribed to increase appetite or otherwise affect weight (increase or decrease).
- Patients with newly prescribed glucocorticoids for less than four weeks at the time of Screening and whose weight is not yet stable are excluded.
- Drugs like Olanzapine are allowed only when used as an antiemetic, as needed (PRN). If used to treat cachexia, drugs like Olanzapine are not allowed.
See the full eligibility criteria
Who can join
- 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.
- Newly diagnosed colorectal adenocarcinoma (CRC) or pancreatic ductal adenocarcinoma (PDAC) that is unresectable, locally advanced (i.e., surgery with curative intent is not an option) or metastatic.
- Determined by the Investigator to be ready to receive their second dose of chemotherapy.
- Patients currently enrolled and receiving study intervention under Protocol Version 2.0 may be eligible to enroll into Protocol Version 3.0, provided the amended protocol has received all regulatory and ethics approvals...
- Patients must be initiating treatment with one of the following chemotherapy regimens: a) Gemcitabine plus nab-paclitaxel (GNP), Gemcitabine plus capecitabine, NALIRIFOX, FOLFOX, FOLFIRI, or FOLFIRINOX are permitted.
- Must be able and willing to safely self-inject daily or be injected by a caregiver.
- Must have evaluable disease by RECIST 1.1.
- ANC ≥ 1.5 × 10\^9/L
- Platelets ≥ 100 × 10\^9/L, or adequate as determined by the medical judgement of the investigator; lab may be repeated as needed to rule out initial transient lab abnormality that does not require medical intervention
- Hemoglobin ≥ 9 g/dL, or adequate as determined by the medical judgement of the investigator; lab may be repeated as needed to rule out initial transient lab abnormality that does not require medical intervention
- AST and ALT ≤ 3 × ULN; if liver metastases, then ≤ 5 ×ULN; lab may be repeated as needed to rule out initial transient lab abnormality that does not require medical intervention
- Bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome; lab may be repeated as needed to rule out initial transient lab abnormality that does not require medical intervention
- Albumin between 3.4 and 5.4 gm/dL or within institutional normal limits, or not considered clinically significant by the investigator
- Creatinine clearance ≥ 50 mL/min (calculated by Cockcroft and Gault equation; lab may be repeated as needed to rule out initial transient lab abnormality that does not require medical intervention
- Normal hemoglobin A1c levels based on institutional normal limits, or not considered clinically significant by the investigator
- NT-Pro-BNP and Troponin (TnI or TnT) are within normal limits or not considered to be clinically significant by the investigator
- If a female of childbearing capability, must have a negative pregnancy test within 2 weeks of starting treatment.
- Fertile men and women must agree to use adequate contraception for the duration of the trial.
- Willing and able to sign informed consent.
- Additional cohort-specific
- CRC Cohort i. Must have a BMI ≤ 29 kg/m\^2.
- PDAC Cohort i. Cachexia defined by Fearon Criteria of weight loss ii. Patients with diagnosed exocrine pancreatic insufficiency (EPI) must be receiving prescription pancreatic enzyme replacement therapy (PERT) per...
What rules you out
- Patients receiving second line or later systemic treatment
- Patients with swallowing abnormalities, malabsorption syndromes, short or inflammatory bowel syndromes, or other conditions that in the Investigator's opinion could impair food consumption or metabolism.
- History of weight loss surgery including gastric stapling, or bypass surgery.
- Currently using any new agent prescribed to increase appetite or otherwise affect weight (increase or decrease).
- Patients with newly prescribed glucocorticoids for less than four weeks at the time of Screening and whose weight is not yet stable are excluded.
- Drugs like Olanzapine are allowed only when used as an antiemetic, as needed (PRN). If used to treat cachexia, drugs like Olanzapine are not allowed.
- Chronic and ongoing use of corticosteroids at a dose of ≥5 mg of prednisone or equivalent per day.
- History of bulimia or anorexia.
- Pregnancy, lactation, or plans to become pregnant.
- History of another malignancy except basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy that has previously undergone potentially curative therapy.
- Concurrent participation in any other clinical trial.
- Patients with known brain or CNS metastases.
- Greater than class II NYHA congestive heart failure
- Congenital long QT syndrome
- QTc \> 470 msec (as calculated by institution standards) confirmed by two ECGs ≥ 1-minute apart (QTc interval corrected using [Fridericia's formula [QTcF])
- Unstable angina pectoris
- Acute myocardial infarction ≤ 6 months prior to study entry
- Known hypersensitivity to mifomelatide or its formulation.
- History of allergic or anaphylactic reaction to any chemotherapeutics.
- Known diagnosis of HIV infection (HIV testing is not mandatory). Patients with a history of HIV regardless of viral load are excluded.
- Active infection with Hepatitis B, Hepatitis C, or active systemic viral disease or active severe infection.
- Unwilling or unable to comply with the protocol.
- Any condition that, in the Investigator's opinion, would impair the patients' ability to participate in this study.
- Additional cohort-specific exclusion criteria
- CRC cohort i. Unintentional weight loss ≥ 10% of usual body weight in 4 months prior to Screening
- PDAC cohort i. Neuroendocrine (carcinoid, islet cell) of acing pancreatic carcinoma ii. Unintentional weight loss ≥ 20% of usual body weight in 4 months prior to Screening
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Santa Monica, California, United States
- Coral Springs, Florida, United States
- Hialeah, Florida, United States
- Margate, Florida, United States
- Miami Beach, Florida, United States
- Tamarac, Florida, United States
- Atlanta, Georgia, United States
- Skokie, Illinois, United States
- Wichita, Kansas, United States
- Detroit, Michigan, United States
- Lincoln, Nebraska, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Memphis, Tennessee, United States
- Kingwood, Texas, United States
- Laredo, Texas, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States; Los Angeles, California, United States; Santa Monica, California, United States; Coral Springs, Florida, United States; Hialeah, Florida, United States; Margate, Florida, United States and 16 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.