NCT06937177ClinicalTrials.gov

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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.

التواصل مع هذه الدراسة

باختصار

المرحلة 2مطلوب 120 مشاركاً26 موقعاًدولتان

الفئات

علم الأورام67%الغدد الصمّاء والأيض18%أمراض الجهاز الهضمي والكبد15%

مسجَّلة في سجل واحد

ClinicalTrials.govNCT06937177فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل شهرين

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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.

الحالات

Cancer Weight Loss

الأهلية

الأهلية
الجنس	الجميع
الأعمار	18 Years – لا حد أقصى
المتطوعون الأصحّاء	لا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسة	تدخّلية
المرحلة	المرحلة 2
التخصيص	معشّاة
نموذج التدخّل	PARALLEL
الغرض الأساسي	TREATMENT
التعمية	QUADRUPLE (4)
التجنيد	مطلوب 120 مشاركاً

الجهة الراعية والمتعاونون

Endevica Bio الجهة الراعية

الأذرع والتدخلات

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

التدخلات

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

مقاييس النتائج

مقياس النتيجة الأولي
Incidence of abnormalities in vital signs
الإطار الزمني From enrollment to the end of the 12 week dosing period
مقياس النتيجة الأولي
Change from baseline in body weight
الإطار الزمني At 12 weeks of treatment
مقياس النتيجة الأولي
Incidence and severity of adverse events (AEs), AESIs, and SAEs
الإطار الزمني From enrollment to the end of the 12 week dosing period
مقياس النتيجة الأولي
Incidence of abnormalities in laboratory evaluations
الإطار الزمني From enrollment to the end of the 12 week dosing period
مقياس النتيجة الثانوي
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.
الإطار الزمني At 12 weeks of treatment
مقياس النتيجة الثانوي
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.
الإطار الزمني At 12 weeks of treatment
مقياس النتيجة الثانوي
Change from baseline in BMI
Weight and height will be combined to report BMI in kg/m\^2
الإطار الزمني At 12 weeks of treatment
مقياس النتيجة الثانوي
Change from baseline in body weight
الإطار الزمني At 8 weeks of treatment
مقياس النتيجة الثانوي
Change from baseline in BMI
Weight and height will be combined to report BMI in kg/m\^2
الإطار الزمني At 8 weeks of treatment
مقياس النتيجة الثانوي
Change from baseline in body weight
الإطار الزمني At 4 weeks of treatment
مقياس النتيجة الثانوي
Change from baseline in BMI
Weight and height will be combined to report BMI in kg/m\^2
الإطار الزمني At 4 weeks of treatment
مقياس النتيجة الثانوي
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.
الإطار الزمني At 12 weeks of treatment
مقياس النتيجة الثانوي
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.
الإطار الزمني At 12 weeks of treatment
مقياس نتيجة آخر
Blood levels of mifomelatide
Plasma concentrations of mifomelatide collected at prespecified sampling timepoints
الإطار الزمني From enrollment to the end of the 12 week treatment period
مقياس نتيجة آخر
Immunogenicity profile of mifomelatide
الإطار الزمني From enrollment to the end of the 12 week treatment period
مقياس نتيجة آخر
Change from baseline in lean mass
Determined by medical imaging
الإطار الزمني From enrollment to the end of the 12 week treatment period
مقياس نتيجة آخر
Change from baseline in fat mass
Determined by medical imaging
الإطار الزمني From enrollment to the end of the 12 week treatment period
مقياس نتيجة آخر
Change from baseline in tumor burden
To determine the response rate by RECIST 1.1 criteria
الإطار الزمني At 12 weeks of treatment
مقياس نتيجة آخر
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
الإطار الزمني From enrollment to the end of 12 week treatment period
مقياس نتيجة آخر
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).
الإطار الزمني From enrollment to the end of 12 week treatment period
مقياس نتيجة آخر
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.
الإطار الزمني From enrollment to the end of 12 week treatment period, Month 6 and Month 9 in OLE
مقياس نتيجة آخر
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).
الإطار الزمني From enrollment through Week 26 in OLE where applicable
مقياس نتيجة آخر
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).
الإطار الزمني From enrollment to death from any cause (including OLE where applicable)

التواريخ

التواريخ
تاريخ البدء	28 أبريل 2025 (فعلي)
الإتمام الأولي	1 أكتوبر 2027 (تقديري)
الإتمام	1 ديسمبر 2027 (تقديري)
أول نشر	22 أبريل 2025 (فعلي)
آخر تحديث	15 يوليو 2026
النتائج منشورة	غير مذكور في سجل السجل
آخر تأكيد للحالة	يوليو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

22 موقعاً قيد التجنيد

Canada

Canada
المنشأة	المدينة	الولاية أو المنطقة	الحالة
Cross Cancer Institute	Edmonton	Alberta	قيد التجنيد

United States

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

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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