Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Metastatic Colorectal Cancer Undergoing Chemotherapy
- Registration Number
- NCT06937177
- Lead Sponsor
- Endevica Bio
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
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Must be at least 18 years of age.
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An ECOG performance status of ≤ 2.
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Life expectancy of ≥ 9 months.
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Able to eat and digest food normally. Patients with colostomies are allowed.
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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.
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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.
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Must have a BMI ≤ 29 kg/m^2.
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Must be able and willing to safely self-inject daily or be injected by a caregiver.
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Must have measurable disease by RECIST 1.1 criteria.
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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
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NT-Pro-BNP and Troponin (TnI or TnT) are within normal limits or not considered to be clinically significant by the investigator.
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If a female of childbearing capability, must have a negative pregnancy test within 2 weeks of starting treatment.
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Fertile men and women must agree to use adequate contraception for the duration of the trial.
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Willing and able to sign informed consent.
Exclusion Criteria
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Patients receiving second line or later systemic treatment for stage IV disease.
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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.
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History of weight loss surgery including gastric stapling, or bypass surgery.
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Unintentional weight loss ≥ 10% of usual body weight in 4 months prior to Screening or other weight loss considered significant by the Investigator.
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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.
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Chronic and ongoing use of corticosteroids at a dose of ≥5 mg of prednisone or equivalent per day.
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History of bulimia or anorexia.
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Pregnancy, lactation, or plans to become pregnant.
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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.
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Concurrent participation in any other clinical trial.
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Patients with known brain or CNS metastases.
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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
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Known hypersensitivity to B07 or its formulation.
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Known diagnosis of HIV infection (HIV testing is not mandatory). Patients with a history of HIV regardless of viral load are excluded.
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Active infection with Hepatitis B, Hepatitis C, or active systemic viral disease or active severe infection.
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Unwilling or unable to comply with the protocol.
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Any condition that, in the Investigator's opinion, would impair the patients' ability to participate in this study.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo administered subcutaneously daily for 12 weeks Placebo - TCMCB07 12.5 mg administered subcutaneously daily for 12 weeks TCMCB07 - TCMCB07 25 mg administered subcutaneously daily for 12 weeks TCMCB07 - TCMCB07 50 mg administered subcutaneously daily for 12 weeks TCMCB07 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 FAACT-ACS score sums 12 items; both use a 5-point scale (0-4).Higher scores are associated with a higher health-related quality of life.
Change from baseline in BMI At 4 weeks of treatment Weight and height will be combined to report BMI in kg/m\^2
Change from baseline in body weight At 4 weeks of treatment Change from baseline in the FAACT questionnaire comprising the general quality of life FAACT-G and FAACT-ACS anorexia and cachexia related subscale At 12 weeks of treatment FAACTG and FAACT ACS score score items using a 5-point scale (0-4).Higher scores are associated with a higher health-related quality of life.
Change from baseline in total score of Functional Assessment of Anorexia/Cachexia Therapy-anorexia-related symptoms scale (FAACT-5IASS) At 12 weeks of treatment FAACT-5IASS scores items using a 5-point scale (0-4).Higher scores are associated with a higher health-related quality of life.
Change from baseline in total score and subscores of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) At 12 weeks of treatment Scoring ranges from 0 to 100 with 0 being the worst possible score and 100 being the best.
Trial Locations
- Locations (1)
Investigative Site
🇨🇦Edmonton, Alberta, Canada
Investigative Site🇨🇦Edmonton, Alberta, Canada