OncoMatch/Clinical Trials/NCT06937177
Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Metastatic Colorectal Cancer Undergoing Chemotherapy
Is NCT06937177 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies TCMCB07 for cancer weight loss.
Treatment: TCMCB07 — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage IV
Metastatic disease required
Newly diagnosed metastatic colorectal adenocarcinoma and about to start first line chemotherapy. Must have measurable disease by RECIST 1.1 criteria.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic treatment for stage IV disease
Exception: first line therapy allowed
Patients receiving second line or later systemic treatment for stage IV disease.
Lab requirements
Blood counts
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
Kidney function
Creatinine clearance ≥ 50 mL/min (calculated by Cockcroft and Gault equation)
Liver function
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
Cardiac function
NT-Pro-BNP and Troponin (TnI or TnT) are within normal limits or not considered to be clinically significant by the investigator
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Investigative Site · Tucson, Arizona
- Investigative Site · Los Angeles, California
- Investigative Site · Los Angeles, California
- Investigative Site · Hialeah, Florida
- Investigative Site · Margate, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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