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

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives:

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

Inclusion Criteria:

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.

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices