NCT06937177ClinicalTrials.gov

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

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

Phase 2120 participants recherchés26 sites2 pays

Catégories

Oncologie67%Endocrinien et métabolique18%Gastro-entérologie et hépatologie15%

Enregistré dans 1 registre

ClinicalTrials.govNCT06937177Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 mois

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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.

Résumé

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.

Affections

Cancer Weight Loss

Éligibilité

Éligibilité
Sexe	Tous
Âges	18 Years – Aucun maximum
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Phase 2
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	QUADRUPLE (4)
Recrutement	120 participants recherchés

Promoteur et collaborateurs

Endevica Bio Promoteur

Groupes et interventions

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

Interventions

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

Critères de jugement

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

Dates

Dates
Date de début	28 avril 2025 (réelle)
Achèvement principal	1 octobre 2027 (estimée)
Achèvement	1 décembre 2027 (estimée)
Première publication	22 avril 2025 (réelle)
Dernière mise à jour	15 juillet 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	juillet 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

22 sites sont en recrutement

Canada

Canada
Établissement	Ville	État ou région	Statut
Cross Cancer Institute	Edmonton	Alberta	En recrutement

United States

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

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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