Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visugromab low dose | Active Comparator |
| |
| Visugromab medium dose | Active Comparator |
| |
| Visugromab high dose | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visugromab (CTL-002) | Drug | High dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in body weight at 12 weeks | 12 weeks | |
| Change from baseline in appetite at 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) | 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Director | Contact | 49 8920006640 | regulatory-006@catalym.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clermont Oncology Center | Not yet recruiting | Clermont | Florida | 34711 | United States | |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
IV infusion |
|
| Visugromab (CTL-002) | Drug | Medium dose |
|
| Visugromab (CTL-002) | Drug | Low dose |
|
| Mid Florida Hematology and Oncology Centers |
| Recruiting |
| Orange City |
| Florida |
| 32763 |
| United States |
| Cleveland Clinic Avon Hospital | Not yet recruiting | Avon | Ohio | 44011 | United States |
| Cleveland Clinic (Main Campus) | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
| Cleveland Clinic Fairview Hospital | Not yet recruiting | Fairview | Ohio | 44111 | United States |
| Cleveland Clinic Hillcrest Hospital | Not yet recruiting | Mayfield Heights | Ohio | 44124 | United States |
| Specialized Hospital for Active Treatment in Oncology | Recruiting | Haskovo | 6300 | Bulgaria |
| Medical Centre Futuremeds Plovdiv | Not yet recruiting | Plovdiv | 4000 | Bulgaria |
| Multiscan, s.r.o., Nemocnice Horovice | Not yet recruiting | Hořovice | 268 01 | Czechia |
| Léon Bérard Center (Centre Léon Bérard) | Recruiting | Lyon | 69008 | France |
| University Hospital Carl Gustav Carus Dresden (Universitätsklinikum Carl Gustav Carus Dresden) | Recruiting | Dresden | 01307 | Germany |
| ASST degli Spedali Civili di Brescia | Recruiting | Brescia | 25123 | Italy |
| Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna | Recruiting | Ferrara | 44124 | Italy |
| Centro Ricerche Cliniche di Verona | Recruiting | Verona | 37134 | Italy |
| Oslo University Hospital | Recruiting | Oslo | 0372 | Norway |
| Akershus University Hospital | Recruiting | Oslo | 1478 | Norway |
| Pratia Onkologia Katowice | Recruiting | Katowice | 40-519 | Poland |
| Jagiellońskie Centrum Innowacji Sp. z o.o. | Recruiting | Krakow | 30-348 | Poland |
| Pratia MCM Kraków | Recruiting | Krakow | 30-727 | Poland |
| Futuremeds Łódź | Not yet recruiting | Lodz | 91-363 | Poland |
| Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi. | Recruiting | Lodz | 93-513 | Poland |
| MS CLINSEARCH Specjalistyczny NZOZ Janusz Milanowski, Katarzyna Szmygin - Milanowska Sp. j. | Not yet recruiting | Lublin | 20-064 | Poland |
| FutureMeds Targówek | Recruiting | Warsaw | 03-505 | Poland |
| Pratia Onkologia Wrocław | Recruiting | Wroclaw | 50-019 | Poland |
| Oncolab Craiova | Not yet recruiting | Craiova | 200385 | Romania |
| St. Nectarie Oncology Center, Craiova | Recruiting | Craiova | 200801 | Romania |
| University Hospital of A Coruña (Hospital Universitario de A Coruña) | Recruiting | A Coruña | 15006 | Spain |
| Futuremeds Hospital Viamed Santa Elena | Not yet recruiting | Madrid | 28003 | Spain |
| Hospital Universitario Puerta de Hierro | Not yet recruiting | Majadahonda | 28222 | Spain |
| Gruppo Ospedaliero Moncucco - Clinica Moncucco | Not yet recruiting | Lugano | 6900 | Switzerland |
| Cantonal Hospital St. Gallen (Kantonsspital St. Gallen) | Recruiting | Sankt Gallen | 9000 | Switzerland |
| University Hospital of Zurich (Universitätsspital Zürich) | Recruiting | Zurich | 8006 | Switzerland |
| Royal Sussex County Hospital | Recruiting | Brighton | BN2 5BE | United Kingdom |
| Ninewells Hospital | Recruiting | Dundee | DD2 1SG | United Kingdom |
| Royal Surrey County Hospital | Recruiting | Guildford | GU2 7XX | United Kingdom |
| ID | Term |
|---|---|
| D002100 | Cachexia |
| D009369 | Neoplasms |
| D015431 | Weight Loss |
| D000855 | Anorexia |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D012817 | Signs and Symptoms, Digestive |
Not provided
Not provided