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

Conditions

• Cancer Weight Loss

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TCMCB07 — DRUG
  TCMCB07 is will be provided in single-use vials for subcutaneous administration
• Placebo — DRUG
  Matching placebo

Study Details

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 locally advanced, unresectable or 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.

Key Dates

Start date

Apr 28, 2025

Status verified

May 2026

Primary completion

Mar 31, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Change from baseline in body weight [ Time Frame: At 12 weeks of treatment ]

Central Contacts

• Daniel Marks, MD/PHD
  503-754-5624
  [email protected]
• LuAnn Sabounjian
  [email protected]

Locations (25)

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