VINCIT is an adaptive, randomized, double-blind, placebo-controlled Phase 2/3 study designed to evaluate the efficacy and safety of visugromab (CTL-002) in patients with cancer-related cachexia. The primary objective of the study is to assess changes in body weight and appetite after 12 weeks of treatment. The study includes adults with advanced malignant diseases and documented weight loss. Randomization is conducted across three visugromab doses (low, medium, high) or placebo in a parallel-group design. The primary endpoints are the change in body weight from baseline and the change in appetite, measured using the 5-item anorexia subscale of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT). Additional endpoints include functional parameters as well as safety and tolerability endpoints.
The VINCIT study is evaluating a new medicine called visugromab in people with advanced cancer who have experienced unintended weight loss known as cachexia. The aim of the study is to determine whether visugromab can help improve body weight and appetite. Researchers will also assess whether treatment improves physical activity and overall functioning. Adults with advanced cancer and weight loss may be eligible to participate. Participants are randomly assigned to receive one of several doses of visugromab or a placebo. The study also evaluates the safety and tolerability of treatment.
