Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo in Patients With Cancer-associated Cachexia
CatalYm GmbH
Summary
A study of how well and safely a new drug called visugromab works in people with certain kinds of cancer (including lung and bowel cancer) and unintended weight loss known as cachexia. The main questions it aims to answer are: * Does visugromab help participants put weight back on and have a better appetite? * Does visugromab help participants move more and better? * What medical problems do participants have when taking visugromab? Researchers will compare visugromab to a placebo (a look-alike substance that contains no drug). Participants will visit the hospital or clinic once every 4 weeks to receive visugromab or placebo via a drip into a vein and to undergo checkups and tests.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Weight loss * Advanced cancer Exclusion Criteria: * Participation in another interventional clinical trial, receipt of any investigational therapy or use of any investigational device within 4 weeks prior to screening and between screening and the first dose of investigational product
Interventions
- DrugVisugromab (CTL-002)
High dose
- DrugPlacebo
IV infusion
- DrugVisugromab (CTL-002)
Medium dose
- DrugVisugromab (CTL-002)
Low dose
Locations (7)
- Mid Florida Hematology and Oncology CentersOrange City, Florida
- Specialized Hospital for Active Treatment in OncologyHaskovo
- Léon Bérard Center (Centre Léon Bérard)Lyon
- Oslo University HospitalOslo
- University Hospital of A Coruña (Hospital Universitario de A Coruña)A Coruña
- Cantonal Hospital St. Gallen (Kantonsspital St. Gallen)Sankt Gallen