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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Weight Loss
• Intervention / Treatment: Drug: Placebo; Drug: TCMCB07

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Daniel Marks, MD/PHD; Phone Number: 503-754-5624; Email: dan@endevicabio.com
• Study Contact Backup: Name: LuAnn Sabounjian; Email: luann@endevicabio.com

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Recruiting
      • Investigative Site
• United States
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Recruiting
      • Investigative Site
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • Investigative Site
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Investigative Site
  • Florida
    • Coral Springs, Florida, United States, 33071
      • Recruiting
      • Investigative Site
    • Hialeah, Florida, United States, 33013
      • Recruiting
      • Investigative Site
    • Margate, Florida, United States, 33063
      • Recruiting
      • Investigative Site
    • Miami Beach, Florida, United States, 33140
      • Recruiting
      • Investigative Site
    • Tamarac, Florida, United States, 33321
      • Recruiting
      • Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Recruiting
      • Investigative Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Not yet recruiting
      • Investigative Site
    • Hinsdale, Illinois, United States, 60521
      • Not yet recruiting
      • Investigative Site
    • Skokie, Illinois, United States, 60077
      • Not yet recruiting
      • Investigative Site
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Recruiting
      • Investigative Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Investigative Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Recruiting
      • Investigative Site
    • Omaha, Nebraska, United States, 68130
      • Recruiting
      • Investigative Site
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • Investigative Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Recruiting
      • Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Not yet recruiting
      • Investigative Site
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • Investigative Site
    • Nashville, Tennessee, United States, 37232
      • Not yet recruiting
      • Investigative Site
  • Texas
    • Kingwood, Texas, United States, 77090
      • Recruiting
      • Investigative Site
    • Laredo, Texas, United States, 78041
      • Recruiting
      • Investigative Site
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo administered subcutaneously daily for 12 weeks	Drug: Placebo; Matching placebo
Experimental: TCMCB07 12.5 mg administered subcutaneously daily for 12 weeks	Drug: TCMCB07; TCMCB07 is will be provided in single-use vials for subcutaneous administration
Experimental: TCMCB07 25 mg administered subcutaneously daily for 12 weeks	Drug: TCMCB07; TCMCB07 is will be provided in single-use vials for subcutaneous administration
Experimental: TCMCB07 50 mg administered subcutaneously daily for 12 weeks	Drug: TCMCB07; TCMCB07 is will be provided in single-use vials for subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in body weight	At 12 weeks of treatment
Incidence and severity of adverse events (AEs)	From enrollment to the end of the 12 week dosing period
Incidence of abnormalities in laboratory evaluations	From enrollment to the end of the 12 week dosing period
Incidence of abnormalities in vital signs	From enrollment to the end of the 12 week dosing period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	At 12 weeks of treatment
Change from baseline in BMI	Weight and height will be combined to report BMI in kg/m^2	At 12 weeks of treatment
Change from baseline in body weight		At 8 weeks of treatment
Change from baseline in BMI	Weight and height will be combined to report BMI in kg/m^2	At 8 weeks of treatment
Change from baseline in body weight		At 4 weeks of treatment
Change from baseline in BMI	Weight and height will be combined to report BMI in kg/m^2	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	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.	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)	Scoring ranges from 0 to 100 with 0 being the worst possible score and 100 being the best.	At 12 weeks of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood levels of B07	A single blood sample will be taken prior to dose during clinic visits to measure the Cmin blood level of B07	From enrollment to the end of the 12 week treatment period
Immunogenicity profile of B07		From enrollment to the end of the 12 week treatment period
Change from baseline in lean mass	Determined by medical imaging	From enrollment to the end of the 12 week treatment period
Change from baseline in fat mass	Determined by medical imaging	From enrollment to the end of the 12 week treatment period
Change from baseline in tumor burden	To determine the response rate by RECIST 1.1 criteria	At 12 weeks of treatment
Effect of B07 on chemotherapy relative dose intensity	Comparison of actual dose intensity ratio versus expected chemotherapy dose intensity ratio between B07 and placebo groups	From enrollment to the end of 12 week treatment period

Collaborators and Investigators

• Sponsor: Endevica Bio

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Weight Loss; Chemotherapy; Cachexia; BMI; Metastatic colorectal cancer; colorectal adenocarcinoma; cancer weight loss; advanced, unresectable colorectal cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Body Weight; Intestinal Diseases; Body Weight Changes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Thinness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Weight Loss; Colorectal Neoplasms; Cachexia; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: TCMCB07-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No