Actively Recruiting
Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Colorectal Cancer Undergoing Chemotherapy
Led by Endevica Bio · Updated on 2026-05-11
120
Participants Needed
26
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Colorectal Cancer Undergoing Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be at least 18 years of age.
- ECOG performance status of 2 or less.
- Life expectancy of 9 months or more.
- Able to eat and digest food normally; patients with colostomies are allowed.
- Newly diagnosed metastatic or unresectable, locally advanced colorectal adenocarcinoma and about to start first line chemotherapy.
- Ready to receive second dose of chemotherapy as determined by investigator.
- Starting chemotherapy with FOLFOX, FOLFIRI, FOLFIRINOX, with or without bevacizumab or other FDA approved agents dosed every 2 weeks.
- BMI of 29 kg/m² or less.
- Able and willing to safely self-inject daily or be injected by a caregiver.
- Evaluable disease by RECIST 1.1.
- Adequate end organ function including ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L (or adequate by investigator), hemoglobin ≥ 9 g/dL (or adequate by investigator), AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastases), bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN with Gilbert's Syndrome), albumin 3.4-5.4 gm/dL or normal, creatinine clearance ≥ 50 mL/min, normal hemoglobin A1c or not clinically significant.
- NT-Pro-BNP and Troponin within normal limits or not clinically significant.
- Negative pregnancy test within 2 weeks if female and of childbearing potential.
- Fertile men and women must use adequate contraception during the trial.
- Willing and able to sign informed consent.
You will not qualify if you...
- Receiving second line or later systemic treatment for stage IV disease.
- Swallowing abnormalities, malabsorption syndromes, short or inflammatory bowel syndromes, or conditions impairing food consumption or metabolism.
- History of weight loss surgery including gastric stapling or bypass.
- Unintentional weight loss of 10% or more in 4 months prior to screening or significant weight loss per investigator.
- Using new agents to increase appetite or affect weight except acceptable antiemetics; chronic THC use allowed, recent androgenic compounds or megestrol acetate use excluded.
- Newly prescribed glucocorticoids less than 4 weeks before screening with unstable weight; stable low dose corticosteroids allowed.
- Chronic corticosteroid use at 5 mg prednisone or more daily.
- History of bulimia or anorexia.
- Pregnancy, lactation, or plans to become pregnant.
- History of other malignancies except certain treated noninvasive cancers.
- Concurrent participation in other clinical trials.
- Known brain or CNS metastases.
- Significant cardiac issues including advanced heart failure, long QT syndrome, prolonged QTc, unstable angina, recent myocardial infarction.
- Known hypersensitivity to B07 or its formulation.
- Known HIV infection or history of HIV.
- Active Hepatitis B, C, systemic viral disease, or severe infection.
- Unwilling or unable to comply with study protocol.
- Any condition impairing ability to participate as judged by investigator.
AI-Screening
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Trial Site Locations
Total: 26 locations
1
Investigative Site
Tucson, Arizona, United States, 85715
Actively Recruiting
2
Investigative Site
Los Angeles, California, United States, 90048
Actively Recruiting
3
Investigative Site
Los Angeles, California, United States, 90095
Actively Recruiting
4
Investigative site
Coral Springs, Florida, United States, 33071
Actively Recruiting
5
Investigative Site
Hialeah, Florida, United States, 33013
Actively Recruiting
6
Investigative Site
Margate, Florida, United States, 33063
Actively Recruiting
7
Investigative Site
Miami Beach, Florida, United States, 33140
Actively Recruiting
8
Investigative Site
Tamarac, Florida, United States, 33321
Actively Recruiting
9
Investigative Site
Atlanta, Georgia, United States, 30318
Actively Recruiting
10
Investigative Site
Chicago, Illinois, United States, 60611
Not Yet Recruiting
11
Investigative Site
Hinsdale, Illinois, United States, 60521
Not Yet Recruiting
12
Investigative Site
Skokie, Illinois, United States, 60077
Not Yet Recruiting
13
Investigative Site
Wichita, Kansas, United States, 67214
Actively Recruiting
14
Investigative Site
Detroit, Michigan, United States, 48201
Actively Recruiting
15
Investigative Site
Lincoln, Nebraska, United States, 68506
Actively Recruiting
16
Investigative Site
Omaha, Nebraska, United States, 68130
Actively Recruiting
17
Investigative Site
New York, New York, United States, 10016
Actively Recruiting
18
Investigative Site
Durham, North Carolina, United States, 27710
Actively Recruiting
19
Investigative Site
Oklahoma City, Oklahoma, United States, 73102
Actively Recruiting
20
Investigative Site
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
21
Investigative Site
Memphis, Tennessee, United States, 38120
Actively Recruiting
22
Investigative site
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
23
Investigative Site
Kingwood, Texas, United States, 77090
Actively Recruiting
24
Investigative Site
Laredo, Texas, United States, 78041
Actively Recruiting
25
Investigative Site
Charlottesville, Virginia, United States, 22908
Actively Recruiting
26
Investigative Site
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
Research Team
D
Daniel Marks, MD/PHD
CONTACT
L
LuAnn Sabounjian
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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