Status:
RECRUITING
Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Metastatic Colorectal Cancer Undergoing Chemotherapy
Lead Sponsor:
Endevica Bio
Conditions:
Cancer Weight Loss
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 metastatic colorectal cancer. This st...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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 colorectal adenocarcinoma and about to start first line chemotherapy.
- 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 measurable disease by RECIST 1.1 criteria.
- 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
- AST and ALT ≤ 3 × ULN; if liver metastases, then ≤ 5 ×ULN
- Bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome
- Albumin between 3.4 and 5.4 gm/dL or within institutional normal limits, or not considered clinically significant by the investigator
- Creatinine clearance ≥ 50 mL/min (calculated by Cockcroft and Gault equation
- Normal hemoglobin A1c levels based on institutional normal limits, or not considered clinically significant by the investigator
- NT-Pro-BNP and Troponin (TnI or TnT) are within normal limits or not considered to be clinically significant by the investigator.
- If a female of childbearing capability, must have a negative pregnancy test within 2 weeks of starting treatment.
- Fertile men and women must agree to use adequate contraception for the duration of the trial.
- Willing and able to sign informed consent.
- Exclusion Criteria
- 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).
- 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:
- Greater than class II NYHA congestive heart failure
- Congenital long QT syndrome
- QTc \> 470 msec (as calculated by institution standards) confirmed by two ECGs ≥ 1-minute apart (interval corrected using \[Bazett's formula \[QTcB\])
- Unstable angina pectoris
- Acute myocardial infarction ≤ 6 months prior to study entry
- Known hypersensitivity to B07 or its formulation.
- Known diagnosis of HIV infection (HIV testing is not mandatory). Patients with a history of HIV regardless of viral load are excluded.
- Active infection with Hepatitis B, Hepatitis C, or active systemic viral disease or active severe infection.
- Unwilling or unable to comply with the protocol.
- Any condition that, in the Investigator's opinion, would impair the patients' ability to participate in this study.
Exclusion
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06937177
Start Date
April 28 2025
End Date
September 1 2026
Last Update
December 12 2025
Active Locations (17)
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1
Investigative Site
Tucson, Arizona, United States, 85715
2
Investigative Site
Los Angeles, California, United States, 90048
3
Investigative Site
Los Angeles, California, United States, 90095
4
Investigative Site
Hialeah, Florida, United States, 33013