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Visugromab in Cachexia International Trial
Sponsor: 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.
Official title: Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo in Patients With Cancer-associated Cachexia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
518
Start Date
2026-04-16
Completion Date
2030-12
Last Updated
2026-05-20
Healthy Volunteers
No
Conditions
Interventions
Visugromab (CTL-002)
High dose
Placebo
IV infusion
Visugromab (CTL-002)
Medium dose
Visugromab (CTL-002)
Low dose
Locations (34)
Clermont Oncology Center
Clermont, Florida, United States
Mid Florida Hematology and Oncology Centers
Orange City, Florida, United States
Cleveland Clinic Avon Hospital
Avon, Ohio, United States
Cleveland Clinic (Main Campus)
Cleveland, Ohio, United States
Cleveland Clinic Fairview Hospital
Fairview, Ohio, United States
Cleveland Clinic Hillcrest Hospital
Mayfield Heights, Ohio, United States
Specialized Hospital for Active Treatment in Oncology
Haskovo, Bulgaria
Medical Centre Futuremeds Plovdiv
Plovdiv, Bulgaria
Multiscan, s.r.o., Nemocnice Horovice
Hořovice, Czechia
Léon Bérard Center (Centre Léon Bérard)
Lyon, France
University Hospital Carl Gustav Carus Dresden (Universitätsklinikum Carl Gustav Carus Dresden)
Dresden, Germany
ASST degli Spedali Civili di Brescia
Brescia, Italy
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna
Ferrara, Italy
Centro Ricerche Cliniche di Verona
Verona, Italy
Oslo University Hospital
Oslo, Norway
Akershus University Hospital
Oslo, Norway
Pratia Onkologia Katowice
Katowice, Poland
Jagiellońskie Centrum Innowacji Sp. z o.o.
Krakow, Poland
Futuremeds Łódź
Lodz, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi.
Lodz, Poland
MS CLINSEARCH Specjalistyczny NZOZ Janusz Milanowski, Katarzyna Szmygin - Milanowska Sp. j.
Lublin, Poland
FutureMeds Targówek
Warsaw, Poland
Pratia Onkologia Wrocław
Wroclaw, Poland
Oncolab Craiova
Craiova, Romania
St. Nectarie Oncology Center, Craiova
Craiova, Romania
University Hospital of A Coruña (Hospital Universitario de A Coruña)
A Coruña, Spain
Futuremeds Hospital Viamed Santa Elena
Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Spain
Gruppo Ospedaliero Moncucco - Clinica Moncucco
Lugano, Switzerland
Cantonal Hospital St. Gallen (Kantonsspital St. Gallen)
Sankt Gallen, Switzerland
University Hospital of Zurich (Universitätsspital Zürich)
Zurich, Switzerland
Royal Sussex County Hospital
Brighton, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Royal Surrey County Hospital
Guildford, United Kingdom