NCT06937177ClinicalTrials.gov

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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

שלב 2דרושים 120 משתתפים26 אתרים2 מדינות

קטגוריות

אונקולוגיה67%אנדוקריני ומטבולי18%גסטרואנטרולוגיה והפטולוגיה15%

רשום במרשם אחד

ClinicalTrials.govNCT06937177פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני חודשיים

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2025-04-22; recorded start 2025-04-28
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1 other study in this databaseCounted from the lead sponsor named in the record (Endevica Bio)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 26 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleSMALL

A small study, international in scope: 120 participants (target), run at 26 sites, across 2 countries.

How this score is built

Enrolment19/40
120 participants (target)
Site count17/25
26 sites
Country count7/15
2 countries
Planned duration8/10
Planned over about 32 months
Sponsor scale1/10
Endevica Bio has led 2 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

תקציר

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.

מצבים רפואיים

Cancer Weight Loss

זכאות

זכאות
מין	הכול
גילאים	18 Years – ללא מקסימום
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

Inclusion Criteria: 1. Must be at least 18 years of age. 2. An ECOG performance status of ≤ 2. 3. Life expectancy of ≥ 4 months. 4. Able to eat and digest food normally. Patients with colostomies are allowed. 5. Must meet the following: 1. 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. Note: patients must not have relapsed within 6 months after completing prior treatment for early-stage disease. 2. Determined by the Investigator to be ready to receive their second dose of chemotherapy. 3. 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 and the patient has reviewed and signed the updated consent form prior to any procedures conducted under the amended protocol. Enrollment into the OLE phase must occur ≤14 days following completion of the Week 12 DB visit. 6. 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. These regimens may be administered with or without bevacizumab, other FDA-approved monoclonal antibodies, or other FDA approved agents as clinically indicated for the patient's cancer type. The primary cancer therapy (including dose, schedule, or specific agents) may be modified as medically indicated. 7. Must be able and willing to safely self-inject daily or be injected by a caregiver. 8. Must have evaluable disease by RECIST 1.1. 9. Must have adequate end organ function as defined by: 1. ANC ≥ 1.5 × 10\^9/L 2. 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 3. 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 4. 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 5. 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 6. Albumin between 3.4 and 5.4 gm/dL or within institutional normal limits, or not considered clinically significant by the investigator; lab may be repeated as needed to rule out initial transient lab abnormality that does not require medical intervention 7. 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 8. Normal hemoglobin A1c levels based on institutional normal limits, or not considered clinically significant by the investigator; lab may be repeated as needed to rule out initial transient lab abnormality that does not require medical intervention 10. NT-Pro-BNP and Troponin (TnI or TnT) are within normal limits or not considered to be clinically significant by the investigator; lab may be repeated as needed to rule out initial transient lab abnormality that does not require medical intervention 11. If a female of childbearing capability, must have a negative pregnancy test within 2 weeks of starting treatment. 12. Fertile men and women must agree to use adequate contraception for the duration of the trial. 13. Willing and able to sign informed consent. 14. Additional cohort-specific inclusion criteria: 1. CRC Cohort i. Must have a BMI ≤ 29 kg/m\^2. 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 standard of care (SOC). Exclusion Criteria 1. Patients receiving second line or later systemic treatment 2. 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. 3. History of weight loss surgery including gastric stapling, or bypass surgery. 4. Currently using any new agent prescribed to increase appetite or otherwise affect weight (increase or decrease). a) Antiemetics or other standard of care medications for treatment or prevention of nausea and vomiting are acceptable. * Patients with newly prescribed glucocorticoids for less than four weeks at the time of Screening and whose weight is not yet stable are excluded. Stable (dose unchanged for 4 weeks or more) and low dose (\<5 mg) corticosteroids are permissible, as are inhaled corticosteroids. * 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. 5. Chronic and ongoing use of corticosteroids at a dose of ≥5 mg of prednisone or equivalent per day. 6. History of bulimia or anorexia. 7. Pregnancy, lactation, or plans to become pregnant. 8. 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. 9. Concurrent participation in any other clinical trial. 10. Patients with known brain or CNS metastases. 11. Impaired cardiac function or significant cardiac issues including, but not limited to, any of the following: 1. Greater than class II NYHA congestive heart failure 2. Congenital long QT syndrome 3. QTc \> 470 msec (as calculated by institution standards) confirmed by two ECGs ≥ 1-minute apart (QTc interval corrected using \[Fridericia's formula \[QTcF\]) 4. Unstable angina pectoris 5. Acute myocardial infarction ≤ 6 months prior to study entry 12. Known hypersensitivity to mifomelatide or its formulation. 13. History of allergic or anaphylactic reaction to any chemotherapeutics. 14. Known diagnosis of HIV infection (HIV testing is not mandatory). Patients with a history of HIV regardless of viral load are excluded. 15. Active infection with Hepatitis B, Hepatitis C, or active systemic viral disease or active severe infection. 16. Unwilling or unable to comply with the protocol. 17. Any condition that, in the Investigator's opinion, would impair the patients' ability to participate in this study. 18. Additional cohort-specific exclusion criteria 1. CRC cohort i. Unintentional weight loss ≥ 10% of usual body weight in 4 months prior to Screening 2. 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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	שלב 2
הקצאה	אקראי
מודל ההתערבות	PARALLEL
מטרה ראשית	TREATMENT
הסתרה	QUADRUPLE (4)
גיוס	דרושים 120 משתתפים

נותן חסות ושותפים

Endevica Bio נותן חסות

זרועות והתערבויות

Placebo administered subcutaneously daily for 12 weeksPLACEBO_COMPARATOR
Mifomelatide (TCMCB07) 12.5 mg administered subcutaneously daily for 12 weeksEXPERIMENTAL
Mifomelatide (TCMCB07) 25 mg administered subcutaneously daily for 12 weeksEXPERIMENTAL
Mifomelatide (TCMCB07) 50 mg administered subcutaneously daily for 12 weeksEXPERIMENTAL

התערבויות

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

מדדי תוצאה

מדד תוצאה ראשוני
Incidence of abnormalities in vital signs
מסגרת זמן From enrollment to the end of the 12 week dosing period
מדד תוצאה ראשוני
Change from baseline in body weight
מסגרת זמן At 12 weeks of treatment
מדד תוצאה ראשוני
Incidence and severity of adverse events (AEs), AESIs, and SAEs
מסגרת זמן From enrollment to the end of the 12 week dosing period
מדד תוצאה ראשוני
Incidence of abnormalities in laboratory evaluations
מסגרת זמן From enrollment to the end of the 12 week dosing period
מדד תוצאה משני
Change from baseline in total score of Functional Assessment of Anorexia/Cachexia Therapy-anorexia-related symptoms scale (FAACT-5IASS)
FAACT-5IASS scores items using a 5-point scale (0-4).Higher scores are associated with a higher health-related quality of life.
מסגרת זמן At 12 weeks of treatment
מדד תוצאה משני
Change from baseline in the anorexia and cachexia subscore of the Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS) questionnaire
FAACT-ACS score sums 12 items; both use a 5-point scale (0-4).Higher scores are associated with a higher health-related quality of life.
מסגרת זמן At 12 weeks of treatment
מדד תוצאה משני
Change from baseline in BMI
Weight and height will be combined to report BMI in kg/m\^2
מסגרת זמן At 12 weeks of treatment
מדד תוצאה משני
Change from baseline in body weight
מסגרת זמן At 8 weeks of treatment
מדד תוצאה משני
Change from baseline in BMI
Weight and height will be combined to report BMI in kg/m\^2
מסגרת זמן At 8 weeks of treatment
מדד תוצאה משני
Change from baseline in body weight
מסגרת זמן At 4 weeks of treatment
מדד תוצאה משני
Change from baseline in BMI
Weight and height will be combined to report BMI in kg/m\^2
מסגרת זמן At 4 weeks of treatment
מדד תוצאה משני
Change from baseline in the FAACT questionnaire comprising the general quality of life FAACT-G and FAACT-ACS anorexia and cachexia related subscale
FAACTG and FAACT ACS score score items using a 5-point scale (0-4).Higher scores are associated with a higher health-related quality of life.
מסגרת זמן At 12 weeks of treatment
מדד תוצאה משני
Change from baseline in total score and subscores of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Scoring ranges from 0 to 100 with 0 being the worst possible score and 100 being the best.
מסגרת זמן At 12 weeks of treatment
מדד תוצאה אחר
Blood levels of mifomelatide
Plasma concentrations of mifomelatide collected at prespecified sampling timepoints
מסגרת זמן From enrollment to the end of the 12 week treatment period
מדד תוצאה אחר
Immunogenicity profile of mifomelatide
מסגרת זמן From enrollment to the end of the 12 week treatment period
מדד תוצאה אחר
Change from baseline in lean mass
Determined by medical imaging
מסגרת זמן From enrollment to the end of the 12 week treatment period
מדד תוצאה אחר
Change from baseline in fat mass
Determined by medical imaging
מסגרת זמן From enrollment to the end of the 12 week treatment period
מדד תוצאה אחר
Change from baseline in tumor burden
To determine the response rate by RECIST 1.1 criteria
מסגרת זמן At 12 weeks of treatment
מדד תוצאה אחר
Effect of mifomelatide on chemotherapy relative dose intensity
Comparison of actual dose intensity ratio versus expected chemotherapy dose intensity ratio between mifomelatide and placebo groups
מסגרת זמן From enrollment to the end of 12 week treatment period
מדד תוצאה אחר
Effect of mifomelatide on time-to-deterioration (TTD) in body weight
Time from first dose of study treatment to first clinically meaningful worsening from baseline appetite score (defined as a 4-point decrease in FAACT-ACS score).
מסגרת זמן From enrollment to the end of 12 week treatment period
מדד תוצאה אחר
Effect of mifomelatide on overall survival at predefined timepoints including Week 12 in the DB and 6 and 9 months in the OLE
Landmark overall survival rates, defined as the proportion of patients alive at each specified timepoint (Week 12, Month 6 and Month 9) following the first dose of study intervention.
מסגרת זמן From enrollment to the end of 12 week treatment period, Month 6 and Month 9 in OLE
מדד תוצאה אחר
Characterize disease progression outcomes in study patients
Progression-free survival (PFS), defined as the time from first documentation of disease progression or death from any cause, whichever occurs first (including OLE where applicable).
מסגרת זמן From enrollment through Week 26 in OLE where applicable
מדד תוצאה אחר
Overall survival
Overall survival (OS), defined as the time from first dose of study drug in the DB phase to death from any cause (including OLE where applicable).
מסגרת זמן From enrollment to death from any cause (including OLE where applicable)

תאריכים

תאריכים
תאריך התחלה	28 באפריל 2025 (בפועל)
סיום ראשוני	1 באוקטובר 2027 (משוער)
סיום	1 בדצמבר 2027 (משוער)
פורסם לראשונה	22 באפריל 2025 (בפועל)
עודכן לאחרונה	15 ביולי 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	יולי 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

22 אתרים מגייסים

Canada

Canada
מתקן	עיר	מדינה או אזור	מצב
Cross Cancer Institute	Edmonton	Alberta	מגייס

United States

United States
מתקן	עיר	מדינה או אזור	מצב
Piedmont Healthcare Inc.	Atlanta	Georgia	מגייס
Medical University of South Carolina	Charleston	South Carolina	טרם מגייס
University of Virginia	Charlottesville	Virginia	מגייס
Northwestern University - Robert H. Lurie Comprehensive Cancer Center	Chicago	Illinois	טרם מגייס
Life Clinical Trials	Coral Springs	Florida	מגייס
Karmanos Cancer Center	Detroit	Michigan	מגייס
Duke University Medical Center	Durham	North Carolina	מגייס
Bioresearch Partners	Hialeah	Florida	מגייס
Hope and Healing Cancer Services	Hinsdale	Illinois	טרם מגייס
Lumi Research	Kingwood	Texas	מגייס
Laguna Clinical Research Associates	Laredo	Texas	מגייס
NHO Revive Research Institute	Lincoln	Nebraska	מגייס
Cedars-Sinai Medical Center	Los Angeles	California	מגייס
D&H Cancer Research Center	Margate	Florida	מגייס
Baptist Clinical Research	Memphis	Tennessee	מגייס
Mt. Sinai Cancer Center	Miami Beach	Florida	מגייס
Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	טרם מגייס
NYU Langone Health Perlmutter Cancer Center	New York	New York	מגייס
Hightower Clinical	Oklahoma City	Oklahoma	מגייס
Nebraska Cancer Specialists	Omaha	Nebraska	מגייס
UCLA Medical Center	Santa Monica	California	מגייס
Orchard Healthcare Research	Skokie	Illinois	מגייס
BRCR Global	Tamarac	Florida	מגייס
Arizona Clinical Research Center	Tucson	Arizona	מגייס
Cancer Centers of Kansas	Wichita	Kansas	מגייס

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06937177