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

NCT06937177 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TCMCB07-01
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 26

Brief 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.

Conditions

Cancer Weight Loss

Keywords

Metastatic colorectal cancer; BMI; Weight Loss; Cachexia; Chemotherapy; advanced, unresectable colorectal cancer; cancer weight loss; colorectal adenocarcinoma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

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

  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

  At 12 weeks of treatment

• Change from baseline in BMI

  At 12 weeks of treatment

• Change from baseline in body weight

  At 8 weeks of treatment

• Change from baseline in BMI

  At 8 weeks of treatment

Other Outcomes (6)

• Blood levels 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

  From enrollment to the end of the 12 week treatment period

Study Arms (4)

Placebo administered subcutaneously daily for 12 weeks

PLACEBO COMPARATOR

Drug: Placebo

TCMCB07 12.5 mg administered subcutaneously daily for 12 weeks

EXPERIMENTAL

Drug: TCMCB07

TCMCB07 25 mg administered subcutaneously daily for 12 weeks

EXPERIMENTAL

Drug: TCMCB07

TCMCB07 50 mg administered subcutaneously daily for 12 weeks

EXPERIMENTAL

Drug: TCMCB07

Interventions

TCMCB07 DRUG

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

TCMCB07 12.5 mg administered subcutaneously daily for 12 weeks; TCMCB07 25 mg administered subcutaneously daily for 12 weeks; TCMCB07 50 mg administered subcutaneously daily for 12 weeks

Placebo DRUG

Matching placebo

Placebo administered subcutaneously daily for 12 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years of age.
• An ECOG performance status of ≤ 2.
• Life expectancy of ≥ 9 months.
• Able to eat and digest food normally. Patients with colostomies are allowed.
• Must meet the following:
• 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.
• Determined by the Investigator to be ready to receive their second dose of chemotherapy.
• 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.
• Must have a BMI ≤ 29 kg/m\^2.
• 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
• Hemoglobin ≥ 9 g/dL, or adequate as determined by the medical judgement of the investigator

You may not qualify if:

• Patients receiving second line or later systemic treatment for stage IV disease.
• 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.
• Unintentional weight loss ≥ 10% of usual body weight in 4 months prior to Screening or other weight loss considered significant by the Investigator.
• 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.
• THC containing agents (e.g., dronabinol, cannabis). Chronic (\> 6 months) use is allowed for THC.
• Other weight promoting agents including androgenic compounds (e.g., testosterone, oxandrolone), dopamine antagonists, or megestrol acetate within the past 6 months is excluded.
• 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.
• 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:

Sponsors & Collaborators

• Endevica Bio: lead

Study Sites (26)

Investigative Site

Tucson, Arizona, 85715, United States

RECRUITING

Investigative Site

Los Angeles, California, 90048, United States

RECRUITING

Investigative Site

Los Angeles, California, 90095, United States

RECRUITING

Investigative site

Coral Springs, Florida, 33071, United States

RECRUITING

Investigative Site

Hialeah, Florida, 33013, United States

RECRUITING

Investigative Site

Margate, Florida, 33063, United States

RECRUITING

Investigative Site

Miami Beach, Florida, 33140, United States

RECRUITING

Investigative Site

Tamarac, Florida, 33321, United States

RECRUITING

Investigative Site

Atlanta, Georgia, 30318, United States

RECRUITING

Investigative Site

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Investigative Site

Hinsdale, Illinois, 60521, United States

NOT YET RECRUITING

Investigative Site

Skokie, Illinois, 60077, United States

NOT YET RECRUITING

Investigative Site

Wichita, Kansas, 67214, United States

RECRUITING

Investigative Site

Detroit, Michigan, 48201, United States

RECRUITING

Investigative Site

Lincoln, Nebraska, 68506, United States

RECRUITING

Investigative Site

Omaha, Nebraska, 68130, United States

RECRUITING

Investigative Site

New York, New York, 10016, United States

RECRUITING

Investigative Site

Durham, North Carolina, 27710, United States

RECRUITING

Investigative Site

Oklahoma City, Oklahoma, 73102, United States

RECRUITING

Investigative Site

Charleston, South Carolina, 29425, United States

NOT YET RECRUITING

Investigative Site

Memphis, Tennessee, 38120, United States

RECRUITING

Investigative site

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

Investigative Site

Kingwood, Texas, 77090, United States

RECRUITING

Investigative Site

Laredo, Texas, 78041, United States

RECRUITING

Investigative Site

Charlottesville, Virginia, 22908, United States

RECRUITING

Investigative Site

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Weight Loss; Cachexia

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Central Study Contacts

Daniel Marks, MD/PHD

CONTACT

503-754-5624; dan@endevicabio.com

LuAnn Sabounjian

CONTACT

luann@endevicabio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study i.e. all study team members and study participants will remain blinded for the duration of the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 22, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (25)