RECRUITING

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

Conditions

Cancer Weight Loss Metastatic colorectal cancer Colorectal carcinoma BMI Weight Loss Cachexia Chemotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 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.

Official Title

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

Quick Facts

Study Start:2025-04-28

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06937177

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 colorectal adenocarcinoma and about to start first line chemotherapy. 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 measurable disease by RECIST 1.1 criteria. 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. 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). 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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 colorectal adenocarcinoma and about to start first line chemotherapy.
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 measurable disease by RECIST 1.1 criteria.
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.
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).
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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Lynette Aleman, RN, BSN

CONTACT

512-343-1092

lynette.aleman@wuxiapptec.com

Study Locations (Sites)

Investigative Site

Tucson, Arizona, 85715

United States

Investigative Site

Los Angeles, California, 90048

United States

Investigative Site

Los Angeles, California, 90095

United States

Investigative Site

Hialeah, Florida, 33013

United States

Investigative Site

Margate, Florida, 33063

United States

Investigative Site

Miami Beach, Florida, 33140

United States

Investigative Site

Tamarac, Florida, 33321

United States

Investigative Site

Atlanta, Georgia, 30318

United States

Investigative Site

Detroit, Michigan, 48201

United States

Investigative Site

Lincoln, Nebraska, 68506

United States

Investigative Site

Omaha, Nebraska, 68130

United States

Investigative Site

Durham, North Carolina, 27710

United States

Investigative Site

Oklahoma City, Oklahoma, 73102

United States

Investigative Site

Laredo, Texas, 78041

United States

Collaborators and Investigators

Sponsor: Endevica Bio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-28

Study Completion Date2026-09

Study Record Updates

Study Start Date2025-04-28

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

Metastatic colorectal cancer
Colorectal carcinoma
BMI
Weight Loss
Cachexia
Chemotherapy

Additional Relevant MeSH Terms

Cancer Weight Loss