Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 2

Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Colorectal Cancer Undergoing Chemotherapy

NCT ID: NCT06937177Sponsor: Endevica BioLast updated: 2026-05-11

Summary

This is a randomized, double-blind, placebo-controlled study of B07, administered daily by subcutaneous (SC) injection, in up to 120 patients with newly diagnosed locally advanced, unresectable or metastatic colorectal cancer. This study will evaluate different doses of B07 on weight, body composition and BMI in patients with sub-optimal BMIs (≤ 29 kg/m\^2). Treatment will start at 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.

Arms & interventions

  • DrugTCMCB07

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

  • DrugPlacebo

    Matching placebo

Outcome measures

Primary

  • Change from baseline in body weight

    Time frame: At 12 weeks of treatment

  • Incidence and severity of adverse events (AEs)

    Time frame: From enrollment to the end of the 12 week dosing period

  • Incidence of abnormalities in laboratory evaluations

    Time frame: From enrollment to the end of the 12 week dosing period

  • Incidence of abnormalities in vital signs

    Time frame: From enrollment to the end of the 12 week dosing period

Secondary

  • Change from baseline in total score of Functional Assessment of Anorexia/Cachexia Therapy-anorexia-related symptoms scale (FAACT-5IASS)

    Time frame: At 12 weeks of treatment

  • Change from baseline in the anorexia and cachexia subscore of the Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS) questionnaire

    Time frame: At 12 weeks of treatment

  • Change from baseline in BMI

    Time frame: At 12 weeks of treatment

  • Change from baseline in body weight

    Time frame: At 8 weeks of treatment

  • Change from baseline in BMI

    Time frame: At 8 weeks of treatment

  • Change from baseline in body weight

    Time frame: At 4 weeks of treatment

  • Change from baseline in BMI

    Time frame: At 4 weeks of treatment

  • Change from baseline in the FAACT questionnaire comprising the general quality of life FAACT-G and FAACT-ACS anorexia and cachexia related subscale

    Time frame: At 12 weeks of treatment

  • 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)

    Time frame: At 12 weeks of treatment

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: 1. Must be at least 18 years of age. 2. An ECOG performance status of ≤ 2. 3. Life expectancy of ≥ 9 months. 4. Able to eat and digest food normally. Patients with colostomies are allowed. 5. Must meet the following: 1. Newly diagnosed metastatic or unresectable, locally advanced (i.e., surgery with curative intent is. not an option) colorectal adenocarcinoma and about to start first line chemotherapy. 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. 6. Starting chemotherapy routines allowed are: FOLFOX, FOLFIRI, or FOLFIRINOX with or without bevacizumab, or other monoclonals or other FDA approved agents to be dosed every 2 weeks. The primary cancer therapy (dose, schedule, or drugs) may be changed as medically indicated. 7. Must have a BMI ≤ 29 kg/m\^2. 8. Must be able and willing to safely self-inject daily or be injected by a caregiver. 9. Must have evaluable disease by RECIST 1.1. 10. 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 3. Hemoglobin ≥ 9 g/dL, or adequate as determined by the medical judgement of the investigator 4. AST and ALT ≤ 3 × ULN; if liver metastases, then ≤ 5 ×ULN 5. Bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome 6. Albumin between 3.4 and 5.4 gm/dL or within institutional normal limits, or not considered clinically significant by the investigator 7. Creatinine clearance ≥ 50 mL/min (calculated by Cockcroft and Gault equation 8. Normal hemoglobin A1c levels based on institutional normal limits, or not considered clinically significant by the investigator 11. NT-Pro-BNP and Troponin (TnI or TnT) are within normal limits or not considered to be clinically significant by the investigator. 12. If a female of childbearing capability, must have a negative pregnancy test within 2 weeks of starting treatment. 13. Fertile men and women must agree to use adequate contraception for the duration of the trial. 14. Willing and able to sign informed consent. Exclusion Criteria 1. Patients receiving second line or later systemic treatment for stage IV disease. 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. Unintentional weight loss ≥ 10% of usual body weight in 4 months prior to Screening or other weight loss considered significant by the Investigator. 5. Currently using any new agent designed to increase appetite or otherwise affect weight (increase or decrease). Antiemetics for control of nausea and vomiting are acceptable. 1. THC containing agents (e.g., dronabinol, cannabis). Chronic (\> 6 months) use is allowed for THC. 2. Other weight promoting agents including androgenic compounds (e.g., testosterone, oxandrolone), dopamine antagonists, or megestrol acetate within the past 6 months is excluded. 3. 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 (\<4 mg) corticosteroids are permissible, as are inhaled corticosteroids. 6. Chronic and ongoing use of corticosteroids at a dose of ≥5 mg of prednisone or equivalent per day. 7. History of bulimia or anorexia. 8. Pregnancy, lactation, or plans to become pregnant. 9. 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. 10. Concurrent participation in any other clinical trial. 11. Patients with known brain or CNS metastases. 12. 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 (interval corrected using \[Bazett's formula \[QTcB\]) 4. Unstable angina pectoris 5. Acute myocardial infarction ≤ 6 months prior to study entry 13. Known hypersensitivity to B07 or its formulation. 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.

Study locations (25)

Investigative Site

Tucson, Arizona, 85715

Recruiting

Investigative Site

Los Angeles, California, 90048

Recruiting

Investigative Site

Los Angeles, California, 90095

Recruiting

Investigative site

Coral Springs, Florida, 33071

Recruiting

Investigative Site

Hialeah, Florida, 33013

Recruiting

Investigative Site

Margate, Florida, 33063

Recruiting

Investigative Site

Miami Beach, Florida, 33140

Recruiting

Investigative Site

Tamarac, Florida, 33321

Recruiting

Investigative Site

Atlanta, Georgia, 30318

Recruiting

Investigative Site

Chicago, Illinois, 60611

Not Yet Recruiting

Investigative Site

Hinsdale, Illinois, 60521

Not Yet Recruiting

Investigative Site

Skokie, Illinois, 60077

Not Yet Recruiting

Investigative Site

Wichita, Kansas, 67214

Recruiting

Investigative Site

Detroit, Michigan, 48201

Recruiting

Investigative Site

Lincoln, Nebraska, 68506

Recruiting

Investigative Site

Omaha, Nebraska, 68130

Recruiting

Investigative Site

New York, New York, 10016

Recruiting

Investigative Site

Durham, North Carolina, 27710

Recruiting

Investigative Site

Oklahoma City, Oklahoma, 73102

Recruiting

Investigative Site

Charleston, South Carolina, 29425

Not Yet Recruiting

Investigative Site

Memphis, Tennessee, 38120

Recruiting

Investigative site

Nashville, Tennessee, 37232

Not Yet Recruiting

Investigative Site

Kingwood, Texas, 77090

Recruiting

Investigative Site

Laredo, Texas, 78041

Recruiting

Investigative Site

Charlottesville, Virginia, 22908

Recruiting
Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Colorectal Cancer Undergoing Chemotherapy | Cancerify