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Cancer Weight LossPhase 2NCT06937177

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

A Phase 2 study testing TCMCB07 in people with Cancer Weight Loss, run by Endevica Bio at 26 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer Weight Loss
What is being tested?
TCMCB07
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
26 sitesin 2 countries
Study dates
28 Apr 2025to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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.
  • Must meet the following:
  • 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.
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  • 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 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.
  • Patients must be initiating treatment with one of the following chemotherapy regimens:
  • 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.
  • Must be able and willing to safely self-inject daily or be injected by a caregiver.
  • Must have evaluable disease by RECIST 1.1.
  • Must have adequate end organ function as defined by:
  • 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; lab may be repeated as needed to rule out initial transient lab abnormality that does not require medical intervention
  • 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; lab may be repeated as needed to rule out initial transient lab abnormality that does not require medical intervention
  • 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
  • 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 inclusion criteria:
  • 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 standard of care (SOC).

Who cannot join

  • 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).
  • 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.
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  • 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.
  • Impaired cardiac function or significant cardiac issues including, but not limited to, any of the following:
  • 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

Trial locations and contacts

26 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Daniel Marks, MD/PHD contact

503-754-5624

dan@endevicabio.com

Meghan Joly, PhD contact

Meghan@endevicabio.com

26 sites in 2 countries

United States25 sites, 25 recruiting

  • Piedmont Healthcare Inc.

    Atlanta, Georgia, 30318

    Eyal Meiri, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Denis Guttridge, PhD

    Not yet recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Matthew Reilley, MD

    Recruiting

  • Northwestern University - Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois, 60611

    Ishan Roy, MD, PhD

    Not yet recruiting

  • Life Clinical Trials

    Coral Springs, Florida, 33071

    Sumit Sawhney, MD

    Recruiting

  • Karmanos Cancer Center

    Detroit, Michigan, 48201

    Wasif Saif, MD

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Aman Opneja, MBBS

    Recruiting

  • Bioresearch Partners

    Hialeah, Florida, 33013

    Luis Rangel, MD

    Recruiting

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521

    Srilata Gundala, MD

    Not yet recruiting

  • Lumi Research

    Kingwood, Texas, 77090

    David Nguyen, MD

    Recruiting

  • Laguna Clinical Research Associates

    Laredo, Texas, 78041

    Eduardo Miranda, MD

    Recruiting

  • NHO Revive Research Institute

    Lincoln, Nebraska, 68506

    Kailash Mosalpuria, MD

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Jun Gong, MD

    Recruiting

  • D&H Cancer Research Center

    Margate, Florida, 33063

    Emilio Araujo-Mino, MD

    Recruiting

  • Baptist Clinical Research

    Memphis, Tennessee, 38120

    Donald Gravenor, MD

    Recruiting

  • Mt. Sinai Cancer Center

    Miami Beach, Florida, 33140

    Recruiting

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

    Rajiv Agarwal, MD

    Not yet recruiting

  • NYU Langone Health Perlmutter Cancer Center

    New York, New York, 10016

    Paul Oberstein, MD

    Recruiting

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102

    Sanjaykumar Hapani, MD

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Joel Michalski, MD, PhD

    Recruiting

  • UCLA Medical Center

    Santa Monica, California, 90404

    Jingran Ji, MD

    Recruiting

  • Orchard Healthcare Research

    Skokie, Illinois, 60077

    Ira Oliff, MD

    Recruiting

  • BRCR Global

    Tamarac, Florida, 33321

    Chintan Gandhi, MD

    Recruiting

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715

    Manuel Modiano, MD

    Recruiting

  • Cancer Centers of Kansas

    Wichita, Kansas, 67214

    Shaker Dakhil, MD

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Michael Sawyer, MD

    Recruiting

Other trials in Canada

About this study

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.

Being tested
TCMCB07, Placebo
Keywords
Metastatic colorectal cancer, BMI, Weight Loss, Cachexia, Chemotherapy, advanced, unresectable colorectal cancer, cancer weight loss, colorectal adenocarcinoma, Pancreatic cancer, PDAC, advanced, unresectable PDAC, metastatic pancreatic cancer, CRC
Medical subject headings
Colorectal Neoplasms, Weight Loss, Cachexia, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TCMCB07Drug

    TCMCB07 is will be provided in single-use vials for subcutaneous administration

  • PlaceboDrug

    Matching placebo

Study groups in NCT06937177
Study groupRoleWhat they receive
Placebo administered subcutaneously daily for 12 weeksPlacebo comparatorNot described
Receives: Drug: Placebo
Mifomelatide (TCMCB07) 12.5 mg administered subcutaneously daily for 12 weeksExperimentalNot described
Receives: Drug: TCMCB07
Mifomelatide (TCMCB07) 25 mg administered subcutaneously daily for 12 weeksExperimentalNot described
Receives: Drug: TCMCB07
Mifomelatide (TCMCB07) 50 mg administered subcutaneously daily for 12 weeksExperimentalNot described
Receives: Drug: TCMCB07

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in body weight

    Measured: At 12 weeks of treatment

  2. Incidence and severity of adverse events (AEs), AESIs, and SAEs

    Measured: From enrollment to the end of the 12 week dosing period

  3. Incidence of abnormalities in laboratory evaluations

    Measured: From enrollment to the end of the 12 week dosing period

  4. Incidence of abnormalities in vital signs

    Measured: From enrollment to the end of the 12 week dosing period

Secondary outcomes (9)

  1. 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.

    Measured: At 12 weeks of treatment

  2. 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.

    Measured: At 12 weeks of treatment

  3. Change from baseline in BMI

    Weight and height will be combined to report BMI in kg/m^2

    Measured: At 12 weeks of treatment

  4. Change from baseline in body weight

    Measured: At 8 weeks of treatment

  5. Change from baseline in BMI

    Weight and height will be combined to report BMI in kg/m^2

    Measured: At 8 weeks of treatment

  6. Change from baseline in body weight

    Measured: At 4 weeks of treatment

  7. Change from baseline in BMI

    Weight and height will be combined to report BMI in kg/m^2

    Measured: At 4 weeks of treatment

  8. 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.

    Measured: At 12 weeks of treatment

  9. 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.

    Measured: At 12 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2025
  2. Study start28 Apr 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06937177
Sponsor's protocol ID
TCMCB07-01
Status last verified
Jul 2026
First submitted
25 Mar 2025
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TCMCB07 in people with Cancer Weight Loss, run by Endevica Bio at 26 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel Marks, MD/PHD (503-754-5624, dan@endevicabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in body weight (time frame: At 12 weeks of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06937177.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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