A Phase 2/3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Visugromab in Patients with Cancer-associated Cachexia

The primary objective is to evaluate the efficacy of visugromab at various dose levels in patients with cancer-associated cachexia (5). The secondary objectives include:

• Investigation of additional efficacy parameters (5).
• Assessment of safety and tolerability (4).
• Evaluation of changes in health-related quality-of-life (HRQoL) from baseline.
• Investigation of pharmacokinetics (6) in peripheral blood.

This clinical trial involves 252 participants diagnosed with cancer-associated cachexia. The study population consists of male and female patients aged 18 years or older. Participants are selected based on the presence of advanced cancer and documented weight loss. Additional protocol-defined criteria are applied during the selection process. The primary objective is to investigate the efficacy of visugromab treatment at various doses.

This adaptive, phase 2/3, randomized, double-blind trial is designed to investigate the efficacy and safety of visugromab compared to a placebo in patients with cancer-associated cachexia. Participants will receive intravenous administration of either the test product or a matching placebo. The study includes a screening visit to evaluate eligibility based on criteria such as age, weight loss, and advanced cancer. The primary endpoints consist of the change from baseline in body weight and appetite at 12 weeks, as measured by the FAACT instrument. Secondary endpoints include assessments of skeletal muscle mass via imaging, functional measures, overall survival, and tumor response, alongside the monitoring of adverse events and pharmacokinetics. The investigation will follow a structured sequence of study visits, including follow-up assessments and an end-of-study visit. Total participant involvement and study duration are contingent upon recruitment and protocol-defined parameters.

Visugromab (CTL-002) is administered as a concentrate for solution for infusion. The experimental medication is delivered via intravenous administration at a dose of 00 mg.

A placebo matching Visugromab (CTL-002) is utilized as a comparator in the study.

The efficacy of visugromab in patients with cancer-associated cachexia is evaluated through several parameters. The primary endpoints consist of the change from baseline in body weight and the change from baseline in appetite at 12 weeks, which is assessed using the 5-item anorexia subscale of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) instrument.

Secondary efficacy endpoints include the following:

• Skeletal muscle mass or index as determined by L3 CT/MRI scan.
• Physical function assessed via the 30-second chair stand test and non-sedentary physical activity.
• Overall survival, tumor response, and responder analysis.
• Patient-reported outcomes utilizing the FAACT, Patient Global Impression of Severity (PGI-S), Patient Global Impression of Change (PGI-C), and EORTC-QLQ-C15 PAL.
• Pharmacokinetic parameters, specifically maximum plasma concentration (Cmax) and minimum plasma concentration (Cmin).