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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
2026-08-10
Healthy Volunteers
No
Conditions
Interventions
Visugromab (CTL-002)
High dose
Placebo
IV infusion
Visugromab (CTL-002)
Medium dose
Visugromab (CTL-002)
Low dose
Locations (65)
Eastern Connecticut Hematology & Oncology
Norwich, Connecticut, United States
Clermont Oncology Center
Clermont, Florida, United States
Mid Florida Hematology and Oncology Centers
Orange City, Florida, United States
Cleveland Clinic Martin Health
Stuart, Florida, United States
Augusta University Medical Center
Augusta, Georgia, United States
Astera Cancer Care
East Brunswick, New Jersey, 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
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISUL
Sofia, Bulgaria
Complex Oncology Center - Vratsa EOOD
Vratsa, Bulgaria
Multiscan, s.r.o., Nemocnice Horovice
Hořovice, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni nemocnice v Motole
Prague, Czechia
CHRU de Brest - Hopital Morvan
Brest, France
AP-HP Hôpital Henri Mondor
Créteil, France
Léon Bérard Center (Centre Léon Bérard)
Lyon, France
Centre Paul Strauss
Strasbourg, France
Johanniter Krankenhaus Bonn
Bonn, Germany
University Hospital Carl Gustav Carus Dresden (Universitätsklinikum Carl Gustav Carus Dresden)
Dresden, Germany
Muenchen Klinik Neuperlach
München, Germany
Centro Riferimento Oncologico - Aviano
Aviano, Italy
ASST degli Spedali Civili di Brescia
Brescia, Italy
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna
Ferrara, Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.
Meldola, Italy
Centro Ricerche Cliniche di Verona
Verona, Italy
Haukeland University Hospital
Bergen, Norway
Sorlandet sykehus HF - Kristiansand
Kristiansand, Norway
Oslo University Hospital
Oslo, Norway
Akershus University Hospital
Oslo, Norway
St. Olavs hospital HF, Universitetssykehuset i Trondheim
Trondheim, Norway
Pratia Onkologia Katowice
Katowice, Poland
Jagiellońskie Centrum Innowacji Sp. z o.o.
Krakow, Poland
Pratia MCM Kraków
Krakow, Poland
FutureMeds Krakow
Krakow, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
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
FutureMeds Sp.zo.o - FutureMeds Wrocław
Wroclaw, Poland
Futuremeds Romania Brasov
Brasov, Romania
Oncolab Craiova
Craiova, Romania
St. Nectarie Oncology Center, Craiova
Craiova, Romania
Futuremeds Romania Galati
Galati, Romania
Spitalul Pelican Oradea
Oradea, Romania
Gral Medical - Oncofort Hospital Pitesti
Piteşti, Romania
University Hospital of A Coruña (Hospital Universitario de A Coruña)
A Coruña, Spain
Hospital Clinic Barcelona
Barcelona, Spain
Futuremeds Hospital Viamed Santa Elena
Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Spain
Tumor Zentrum Aarau
Aarau, Switzerland
Istituto Oncologico della Svizzera Italiana
Bellinzona, Switzerland
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
Addenbrooke's Hospital
Cambridge, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Royal Surrey County Hospital
Guildford, United Kingdom
The Christie
Manchester, United Kingdom