NCT06937177ClinicalTrials.gov

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

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Kurz gefasst

Phase 2120 Teilnehmende gesucht26 Studienzentren2 Länder

Kategorien

Onkologie67%Endokrin und metabolisch18%Gastroenterologie und Hepatologie15%

In 1 Register registriert

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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.

Zusammenfassung

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.

Erkrankungen

Cancer Weight Loss

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 2
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	QUADRUPLE (4)
Teilnahme	120 Teilnehmende gesucht

Sponsor und Mitwirkende

Endevica Bio Sponsor

Studienarme und Interventionen

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

Interventionen

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

Endpunkte

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

Daten

Daten
Startdatum	28. April 2025 (tatsächlich)
Primärer Abschluss	1. Oktober 2027 (geschätzt)
Abschluss	1. Dezember 2027 (geschätzt)
Erstveröffentlichung	22. April 2025 (tatsächlich)
Zuletzt aktualisiert	15. Juli 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Juli 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

22 Studienzentren rekrutieren

Canada

Canada
Einrichtung	Stadt	Bundesland oder Region	Status
Cross Cancer Institute	Edmonton	Alberta	Rekrutiert

United States

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

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

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