Endevica Bio, TCMCB07-01, Ph2, Open-label, dbl-blind, Colon Cancer, TCMCB07 vs placebo

What is the Purpose of this Study?

Primary Objective: To evaluate the safety of B07. Secondary Objectives: To evaluate the effect of B07 by dose level on weight, BMI, and body composition relative to placebo, over 28 days in newly diagnosed metastatic colorectal cancer patients. To examine the effect of B07 vs. placebo on appetite in newly diagnosed metastatic colorectal cancer patients To determine the effect of B07 treatment on general patient well-being. To evaluate the blood level of B07 in this population. To determine the immunogenicity profile of B07

Eligibility

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.

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 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.

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).
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.

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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Ana Martin

More about this Clinical Trial

What is the full name of this clinical trial?

TCMCB07-01: Optimizing Body Mass Index with TCMCB07 in Patients with Newly Diagnosed Metastatic Colorectal Cancer Undergoing Chemotherapy

Study Details

Disease Type/Condition

Colon

Principal Investigator

Gong, Jun

Co-Investigators

Andrew Hendifar, Arsen Osipov, Emily Kaymen

Age Group

Adult

Phase

II (Cancer Prevention)

IRB Number

STUDY00004194

ClinicalTrials.gov ID

NCT06937177

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Ana Martin

ana.martin@cshs.org