Visugromab in Cachexia International Trial

NCT07112196 — Phase 2 / Phase 3, Recruiting, 518 participants, CatalYm GmbH
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT07112196, acronym VINCIT
StatusRecruiting
PhasePhase 2 / Phase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment518 (Estimated)
SponsorCatalYm GmbH (Industry)
ConditionsCancer-associated Cachexia
InterventionsVisugromab (CTL-002), Placebo (Drug)
Datesstart 2026-04-16, primary completion 2029-12-01 (estimated), completion 2030-12-01 (estimated), first posted 2025-08-08, last updated 2026-09-22
Locations74 sites in United States, Bulgaria, Czechia, France, Germany, Italy, Norway, Poland and 4 more countries

Related Papers Related Patents Related Grants Related Experts
All trials for Cancer-associated Cachexia All trials of Visugromab (CTL-002) All trials of Placebo

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Visugromab low doseActive comparatorDrug: Visugromab (CTL-002)
Visugromab medium doseActive comparatorDrug: Visugromab (CTL-002)
Visugromab high doseActive comparatorDrug: Visugromab (CTL-002)
PlaceboPlacebo comparatorDrug: Placebo
  • Visugromab (CTL-002) (Drug): High dose
  • Placebo (Drug): IV infusion
  • Visugromab (CTL-002) (Drug): Medium dose
  • Visugromab (CTL-002) (Drug): Low dose

+Outcome measures

Primary outcomes

  • Change from baseline in body weight at 12 weeks [12 weeks]
  • Change from baseline in appetite at 12 weeks [12 weeks]: Measured on the 5-item anorexia subscale of the Functional Assessment of Anorexia/Cachexia Therapy instrument (minimum score 0, maximum 20; higher is better outcome)

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (74)

FacilityCityCountryStatus
Eastern Connecticut Hematology & OncologyNorwich, ConnecticutUnited StatesRecruiting
Clermont Oncology CenterClermont, FloridaUnited StatesRecruiting
Mid Florida Hematology and Oncology CentersOrange City, FloridaUnited StatesRecruiting
Cleveland Clinic Martin HealthStuart, FloridaUnited StatesRecruiting
Augusta University Medical CenterAugusta, GeorgiaUnited StatesRecruiting
Astera Cancer CareEast Brunswick, New JerseyUnited StatesRecruiting
Cleveland Clinic Avon HospitalAvon, OhioUnited StatesRecruiting
Cleveland Clinic (Main Campus)Cleveland, OhioUnited StatesRecruiting
Cleveland Clinic Fairview HospitalFairview, OhioUnited StatesRecruiting
Cleveland Clinic Hillcrest HospitalMayfield Heights, OhioUnited StatesRecruiting
Specialized Hospital for Active Treatment in OncologyHaskovoBulgariaRecruiting
Medical Centre Futuremeds PlovdivPlovdivBulgariaRecruiting
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISULSofiaBulgariaRecruiting
Complex Oncology Center - Vratsa EOODVratsaBulgariaRecruiting
Multiscan, s.r.o., Nemocnice HoroviceHořoviceCzechiaRecruiting
Fakultni nemocnice Hradec KraloveHradec KrálovéCzechiaRecruiting
Fakultni nemocnice OlomoucOlomoucCzechiaRecruiting
Vseobecna fakultni nemocnice v PrazePragueCzechiaRecruiting
Fakultni nemocnice v MotolePragueCzechiaRecruiting
CHRU de Brest - Hopital MorvanBrestFranceRecruiting
AP-HP Hôpital Henri MondorCréteilFranceRecruiting
Léon Bérard Center (Centre Léon Bérard)LyonFranceRecruiting
HCL Centre Hospitalier Lyon SudLyonFranceRecruiting
Centre Paul StraussStrasbourgFranceRecruiting
Johanniter Krankenhaus BonnBonnGermanyRecruiting
University Hospital Carl Gustav Carus Dresden (Universitätsklinikum Carl Gustav Carus Dresden)DresdenGermanyRecruiting
LungenClinic Grosshansdorf GmbHGroßhansdorfGermanyRecruiting
Muenchen Klinik NeuperlachMünchenGermanyRecruiting
Centro Riferimento Oncologico - AvianoAvianoItalyRecruiting
ASST degli Spedali Civili di BresciaBresciaItalyRecruiting
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'AnnaFerraraItalyRecruiting
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.MeldolaItalyRecruiting
Centro Ricerche Cliniche di VeronaVeronaItalyRecruiting
Haukeland University HospitalBergenNorwayRecruiting
Sorlandet sykehus HF - KristiansandKristiansandNorwayRecruiting
Oslo University HospitalOsloNorwayRecruiting
Akershus University HospitalOsloNorwayRecruiting
St. Olavs hospital HF, Universitetssykehuset i TrondheimTrondheimNorwayRecruiting
Pratia Onkologia KatowiceKatowicePolandRecruiting
Jagiellońskie Centrum Innowacji Sp. z o.o.KrakowPolandRecruiting
Pratia MCM KrakówKrakowPolandRecruiting
FutureMeds KrakowKrakowPolandRecruiting
Szpital Specjalistyczny im. Ludwika Rydygiera w KrakowieKrakowPolandRecruiting
Futuremeds ŁódźLodzPolandRecruiting
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi.LodzPolandRecruiting
MS CLINSEARCH Specjalistyczny NZOZ Janusz Milanowski, Katarzyna Szmygin - Milanowska Sp. j.LublinPolandRecruiting
FutureMeds TargówekWarsawPolandRecruiting
Pratia Onkologia WrocławWroclawPolandRecruiting
FutureMeds Sp.zo.o - FutureMeds WrocławWroclawPolandRecruiting
Futuremeds Romania BrasovBrasovRomaniaRecruiting
Oncolab CraiovaCraiovaRomaniaRecruiting
St. Nectarie Oncology Center, CraiovaCraiovaRomaniaRecruiting
Futuremeds Romania GalatiGalatiRomaniaRecruiting
Spitalul Pelican OradeaOradeaRomaniaRecruiting
Ovidius Clinical HospitalOvidiuRomaniaRecruiting
Gral Medical - Oncofort Hospital PitestiPiteştiRomaniaRecruiting
Oncomed S.R.L.TimișoaraRomaniaRecruiting
University Hospital of A Coruña (Hospital Universitario de A Coruña)A CoruñaSpainRecruiting
Hospital Clinic BarcelonaBarcelonaSpainRecruiting
Futuremeds Hospital Viamed Santa ElenaMadridSpainRecruiting
Hospital Universitario Puerta de HierroMajadahondaSpainRecruiting
Tumor Zentrum AarauAarauSwitzerlandRecruiting
Universitaetsspital BaselBaselSwitzerlandRecruiting
Istituto Oncologico della Svizzera ItalianaBellinzonaSwitzerlandRecruiting
Gruppo Ospedaliero Moncucco - Clinica MoncuccoLuganoSwitzerlandRecruiting
Cantonal Hospital St. Gallen (Kantonsspital St. Gallen)Sankt GallenSwitzerlandRecruiting
University Hospital of Zurich (Universitätsspital Zürich)ZurichSwitzerlandRecruiting
Royal Sussex County HospitalBrightonUnited KingdomRecruiting
Addenbrooke's HospitalCambridgeUnited KingdomRecruiting
Ninewells HospitalDundeeUnited KingdomRecruiting
Western General HospitalEdinburghUnited KingdomRecruiting
Royal Surrey County HospitalGuildfordUnited KingdomRecruiting
The ChristieManchesterUnited KingdomRecruiting
Freeman HospitalNewcastle upon TyneUnited KingdomRecruiting