Visugromab in Cachexia International Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Visugromab (CTL-002), Placebo, Visugromab (CTL-002), Visugromab (CTL-002).
- Who it may be relevant to
- Registry conditions: Cancer-associated Cachexia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Bulgaria, Czechia, France, Germany +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Visugromab (CTL-002)
High dose - Drug Placebo
IV infusion - Drug Visugromab (CTL-002)
Medium dose - Drug Visugromab (CTL-002)
Low dose
Primary outcome measures
- Change from baseline in body weight at 12 weeks [Time frame: 12 weeks]
- Change from baseline in appetite at 12 weeks [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Poland · 10 centers
- Pratia Onkologia Katowice — Katowice
- Jagiellońskie Centrum Innowacji Sp. z o.o. — Krakow
- Pratia MCM Kraków — Krakow
- FutureMeds Krakow — Krakow
- Futuremeds Łódź — Lodz
- Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodz — Lodz
- MS CLINSEARCH Specjalistyczny NZOZ Janusz Milanowski, Katarzyna Szmygin - Milanowska Sp. j — Lublin
- FutureMeds Targówek — Warsaw
- … and 2 more centers
United States · 8 centers
- Eastern Connecticut Hematology & Oncology — Norwich
- Clermont Oncology Center — Clermont
- Mid Florida Hematology and Oncology Centers — Orange City
- Astera Cancer Care — East Brunswick
- Cleveland Clinic Avon Hospital — Avon
- Cleveland Clinic (Main Campus) — Cleveland
- Cleveland Clinic Fairview Hospital — Fairview
- Cleveland Clinic Hillcrest Hospital — Mayfield Heights
Romania · 6 centers
- Futuremeds Romania Brasov — Brasov
- Oncolab Craiova — Craiova
- St. Nectarie Oncology Center, Craiova — Craiova
- Futuremeds Romania Galati — Galati
- Spitalul Pelican Oradea — Oradea
- Gral Medical - Oncofort Hospital Pitesti — Piteşti
Italy · 5 centers
- Centro Riferimento Oncologico - Aviano — Aviano
- ASST degli Spedali Civili di Brescia — Brescia
- Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna — Ferrara
- IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l. — Meldola
- Centro Ricerche Cliniche di Verona — Verona
Norway · 5 centers
- Haukeland University Hospital — Bergen
- Sorlandet sykehus HF - Kristiansand — Kristiansand
- Oslo University Hospital — Oslo
- Akershus University Hospital — Oslo
- St. Olavs hospital HF, Universitetssykehuset i Trondheim — Trondheim
Bulgaria · 4 centers
- Specialized Hospital for Active Treatment in Oncology — Haskovo
- Medical Centre Futuremeds Plovdiv — Plovdiv
- University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISUL — Sofia
- Complex Oncology Center - Vratsa EOOD — Vratsa
Switzerland · 4 centers
- Tumor Zentrum Aarau — Aarau
- Gruppo Ospedaliero Moncucco - Clinica Moncucco — Lugano
- Cantonal Hospital St. Gallen (Kantonsspital St. Gallen) — Sankt Gallen
- University Hospital of Zurich (Universitätsspital Zürich) — Zurich
Czechia · 3 centers
- Multiscan, s.r.o., Nemocnice Horovice — Hořovice
- Fakultni nemocnice Hradec Kralove — Hradec Králové
- Fakultni nemocnice v Motole — Prague
France · 3 centers
- CHRU de Brest - Hopital Morvan — Brest
- Léon Bérard Center (Centre Léon Bérard) — Lyon
- Centre Paul Strauss — Strasbourg
Spain · 3 centers
- University Hospital of A Coruña (Hospital Universitario de A Coruña) — A Coruña
- Futuremeds Hospital Viamed Santa Elena — Madrid
- Hospital Universitario Puerta de Hierro — Majadahonda
United Kingdom · 3 centers
- Royal Sussex County Hospital — Brighton
- Ninewells Hospital — Dundee
- Royal Surrey County Hospital — Guildford
Germany · 2 centers
- Johanniter Krankenhaus Bonn — Bonn
- University Hospital Carl Gustav Carus Dresden (Universitätsklinikum Carl Gustav Carus Dres — Dresden
Identifiers
NCT: NCT07112196 · CTL-002-006