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NCT07112196PHASE2, PHASE3Recruiting

Visugromab in Cachexia International Trial

CatalYm GmbH

Start Date

4/16/2026

Completion Date

12/1/2030

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 Criteria

Age Range: 18 years to No maximum

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

DRUG

Visugromab (CTL-002)

DRUG

Placebo

DRUG

Visugromab (CTL-002)

DRUG

Visugromab (CTL-002)

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Conditions

Cancer-associated Cachexia

Locations

Eastern Connecticut Hematology & Oncology

Norwich, Connecticut 06360

United States

Clermont Oncology Center

Clermont, Florida 34711

United States

Mid Florida Hematology and Oncology Centers

Orange City, Florida 32763

United States

Astera Cancer Care

East Brunswick, New Jersey 08816

United States

Cleveland Clinic Avon Hospital

Avon, Ohio 44011

United States

Cleveland Clinic (Main Campus)

Cleveland, Ohio 44195

United States

Cleveland Clinic Fairview Hospital

Fairview, Ohio 44111

United States

Cleveland Clinic Hillcrest Hospital

Mayfield Heights, Ohio 44124

United States

Specialized Hospital for Active Treatment in Oncology

Haskovo, 6300

Bulgaria

Medical Centre Futuremeds Plovdiv

Plovdiv, 4000

Bulgaria

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISUL

Sofia, 1527

Bulgaria

Complex Oncology Center - Vratsa EOOD

Vratsa, 3001

Bulgaria

Multiscan, s.r.o., Nemocnice Horovice

Hořovice, 268 01

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05

Czechia

Fakultni nemocnice v Motole

Prague, 15006

Czechia

CHRU de Brest - Hopital Morvan

Brest, 29200

France

Léon Bérard Center (Centre Léon Bérard)

Lyon, 69008

France

Centre Paul Strauss

Strasbourg, 67200

France

Johanniter Krankenhaus Bonn

Bonn, 53113

Germany

University Hospital Carl Gustav Carus Dresden (Universitätsklinikum Carl Gustav Carus Dresden)

Dresden, 01307

Germany

Centro Riferimento Oncologico - Aviano

Aviano, 33081

Italy

ASST degli Spedali Civili di Brescia

Brescia, 25123

Italy

Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna

Ferrara, 44124

Italy

IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.

Meldola, 47014

Italy

Centro Ricerche Cliniche di Verona

Verona, 37134

Italy

Haukeland University Hospital

Bergen, 5009

Norway

Sorlandet sykehus HF - Kristiansand

Kristiansand, 4615

Norway

Oslo University Hospital

Oslo, 0372

Norway

Akershus University Hospital

Oslo, 1478

Norway

St. Olavs hospital HF, Universitetssykehuset i Trondheim

Trondheim, 7030

Norway

Pratia Onkologia Katowice

Katowice, 40-519

Poland

Jagiellońskie Centrum Innowacji Sp. z o.o.

Krakow, 30-348

Poland

Pratia MCM Kraków

Krakow, 30-727

Poland

FutureMeds Krakow

Krakow, 31-501

Poland

Futuremeds Łódź

Lodz, 91-363

Poland

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi.

Lodz, 93-513

Poland

MS CLINSEARCH Specjalistyczny NZOZ Janusz Milanowski, Katarzyna Szmygin - Milanowska Sp. j.

Lublin, 20-064

Poland

FutureMeds Targówek

Warsaw, 03-505

Poland

Pratia Onkologia Wrocław

Wroclaw, 50-019

Poland

FutureMeds Sp.zo.o - FutureMeds Wrocław

Wroclaw, 53-673

Poland

Futuremeds Romania Brasov

Brasov, 500052

Romania

Oncolab Craiova

Craiova, 200385

Romania

St. Nectarie Oncology Center, Craiova

Craiova, 200801

Romania

Futuremeds Romania Galati

Galati, 800001

Romania

Spitalul Pelican Oradea

Oradea, 410450

Romania

Gral Medical - Oncofort Hospital Pitesti

Piteşti, 110283

Romania

University Hospital of A Coruña (Hospital Universitario de A Coruña)

A Coruña, 15006

Spain

Futuremeds Hospital Viamed Santa Elena

Madrid, 28003

Spain

Hospital Universitario Puerta de Hierro

Majadahonda, 28222

Spain

Tumor Zentrum Aarau

Aarau, 5000

Switzerland

Gruppo Ospedaliero Moncucco - Clinica Moncucco

Lugano, 6900

Switzerland

Cantonal Hospital St. Gallen (Kantonsspital St. Gallen)

Sankt Gallen, 9000

Switzerland

University Hospital of Zurich (Universitätsspital Zürich)

Zurich, 8006

Switzerland

Royal Sussex County Hospital

Brighton, BN2 5BE

United Kingdom

Ninewells Hospital

Dundee, DD2 1SG

United Kingdom

Royal Surrey County Hospital

Guildford, GU2 7XX

United Kingdom