RecruitingPhase 2Phase 3NCT07112196

Visugromab in Cachexia International Trial

Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo in Patients With Cancer-associated Cachexia


Sponsor

CatalYm GmbH

Enrollment

518 participants

Start Date

Apr 16, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • Weight loss
  • Advanced cancer

Exclusion Criteria1

  • 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

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Interventions

DRUGVisugromab (CTL-002)

High dose

DRUGPlacebo

IV infusion

DRUGVisugromab (CTL-002)

Medium dose

DRUGVisugromab (CTL-002)

Low dose


Locations(35)

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

Pratia MCM Kraków

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

View Full Details on ClinicalTrials.gov

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NCT07112196