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

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Investigative Site
NOT_YET_RECRUITING
Tucson
California
Investigative Site
NOT_YET_RECRUITING
Los Angeles
Investigative Site
NOT_YET_RECRUITING
Los Angeles
Florida
Investigative Site
RECRUITING
Hialeah
Investigative Site
RECRUITING
Margate
Investigative Site
RECRUITING
Miami Beach
Investigative Site
RECRUITING
Tamarac
Georgia
Investigative Site
RECRUITING
Atlanta
Kansas
Investigative Site
RECRUITING
Wichita
Michigan
Investigative Site
RECRUITING
Detroit
North Carolina
Investigative Site
NOT_YET_RECRUITING
Durham
Nebraska
Investigative Site
RECRUITING
Lincoln
Investigative Site
RECRUITING
Omaha
Oklahoma
Investigative Site
RECRUITING
Oklahoma City
Texas
Investigative Site
RECRUITING
Kingwood
Investigative Site
RECRUITING
Laredo
Other Locations
Canada
Investigative Site
NOT_YET_RECRUITING
Edmonton
Contact Information
Primary
Lynette Aleman, RN, BSN
lynette.aleman@wuxiapptec.com
512-343-1092
Time Frame
Start Date: 2025-04-28
Estimated Completion Date: 2026-09
Participants
Target number of participants: 120
Treatments
Placebo_comparator: Placebo administered subcutaneously daily for 12 weeks
Experimental: TCMCB07 12.5 mg administered subcutaneously daily for 12 weeks
Experimental: TCMCB07 25 mg administered subcutaneously daily for 12 weeks
Experimental: TCMCB07 50 mg administered subcutaneously daily for 12 weeks
Related Therapeutic Areas
Sponsors
Leads: Endevica Bio

This content was sourced from clinicaltrials.gov