Clinical trial • Phase II/III • Oncology|Other
VISUGROMAB for Cancer-associated cachexia|Cancer cachexia
Phase II/III trial of VISUGROMAB for Cancer-associated cachexia|Cancer cachexia.
Overview
- Trial Therapeutic Area
- Oncology|Other
- Trial Disease
- Cancer-associated cachexia|Cancer cachexia
- Trial Stage
- Phase II/III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 10-10-2025
- First CTIS Authorization Date
- 13-02-2026
Trial design
Randomised, visugromab (ctl-002) intravenous concentrate for solution for infusion versus placebo matching visugromab (ctl-002); dose and schedule not specified in ctis record.-controlled, adaptive Phase II/III trial in Italy, Bulgaria, Czechia and others.
- Randomised
- Yes
- Comparator
- Visugromab (CTL-002) intravenous concentrate for solution for infusion versus Placebo matching Visugromab (CTL-002); dose and schedule not specified in CTIS record.
- Adaptive
- True, Adaptive phase 2/3 design evaluating visugromab at various doses; protocol text indicates multiple doses/ dose-ranging but specific dose-escalation rules, interim analyses or stopping rules are not provided in the CTIS metadata.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 252
Eligibility
Recruits 252 adults.
Inclusion criteria
- {"criterion_text":"- 1. Male and female participants aged ≥ 18 years at screening\n- 2. Weight loss\n- 3. Advanced cancer\n- 4. Other protocol-defined criteria apply"}
Exclusion criteria
- {"criterion_text":"- 1. 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\n- 2. Other protocol-defined criteria apply"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline in body weight at 12 weeks; change from baseline in appetite at 12 weeks, measured on the 5-item anorexia subscale of the FAACT instrument, 12 weeks","definition_or_measurement_approach":"Change from baseline in body weight at 12 weeks; change from baseline in appetite at 12 weeks measured on the 5-item anorexia subscale of the FAACT instrument (timepoint: 12 weeks)."}
Secondary endpoints
- {"endpoint_text":"- 1. Skeletal muscle mass/index by L3 CT/MRI scan; Functional endpoint (30-second chair stand test); Non-sedentary physical activity; Overall survival (OS); Tumor response; Responder analysis","definition_or_measurement_approach":"Skeletal muscle mass/index assessed by L3 CT/MRI; functional endpoint measured by 30-second chair stand test; non-sedentary physical activity (method not specified); overall survival (OS); tumor response (method not specified); responder analysis (method not specified)."}
- {"endpoint_text":"- 2. Incidence, type, and severity of treatment emergent Adverse Events (TEAEs), treatment-related AEs and serious AEs (SAEs), discontinuation due to TEAEs","definition_or_measurement_approach":"Incidence, type and severity of TEAEs, treatment-related AEs and SAEs, and discontinuations due to TEAEs (standard safety reporting; specific grading/reporting criteria not provided in CTIS record)."}
- {"endpoint_text":"- 3. Patient-reported outcomes: Functional Assessment of Anorexia/Cachexia Therapy (FAACT); Patient Global Impression of Severity (PGI-S); Patient Global Impression of Change (PGI-C); EORTC-QLQ-C15 PAL","definition_or_measurement_approach":"Patient-reported outcomes measured using FAACT, PGI-S, PGI-C and EORTC-QLQ-C15-PAL instruments (specific timepoints not detailed here)."}
- {"endpoint_text":"- 4. Maximum plasma concentration (Cmax); Minimum plasma concentration (Cmin)","definition_or_measurement_approach":"Pharmacokinetic endpoints: Cmax and Cmin in plasma (sampling schedule not provided in CTIS record)."}
Recruitment
- Planned Sample Size
- 252
- Recruitment Window Months
- 40
- Consent Approach
- Informed consent obtained from adult participants (participants aged ≥ 18 years). Subject information and informed consent forms (ICFs) and related participant materials are available in multiple languages (document titles show EN, BG, CS, FR, DE, IT, NO, PL, RO, ES). Separate pregnancy-related ICFs and Data Privacy ICFs are listed among submitted documents. Specific assent/consent procedures text not included in the CTIS metadata.
Geography
- Total Number Of Sites
- 64
- Total Number Of Participants
- 374
Italy
- Earliest CTIS Part Ii Submission Date
- 22-01-2026
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 26
- Number Of Sites
- 5
- Number Of Participants
- 44
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- S.C.Oncologia Medica
- Principal Investigator Name
- Alfredo Berruti
- Principal Investigator Email
- alfredo.berruti@unibs.it
- Contact Person Name
- Alfredo Berruti
- Contact Person Email
- alfredo.berruti@unibs.it
- Site Name
- Centro Di Riferimento Oncologico Di Aviano
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Simon Spazzapan
- Principal Investigator Email
- spazzapan@cro.it
- Contact Person Name
- Simon Spazzapan
- Contact Person Email
- spazzapan@cro.it
- Site Name
- Universita' Degli Studi Di Ferrara
- Department Name
- UO Oncologia
- Principal Investigator Name
- Giuseppe Bronte
- Principal Investigator Email
- giuseppe.bronte@unife.it
- Contact Person Name
- Giuseppe Bronte
- Contact Person Email
- giuseppe.bronte@unife.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Oncologia
- Principal Investigator Name
- Lorenzo Belluomini
- Principal Investigator Email
- lorenzo.belluomini@univr.it
- Contact Person Name
- Lorenzo Belluomini
- Contact Person Email
- lorenzo.belluomini@univr.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia
- Principal Investigator Name
- Paola Cravero
- Principal Investigator Email
- paola.cravero@irst.emt.it
- Contact Person Name
- Paola Cravero
- Contact Person Email
- paola.cravero@irst.emt.it
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 10-12-2025
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 154
- Number Of Sites
- 4
- Number Of Participants
- 23
Sites
- Site Name
- Complex Oncology Center Vratsa EOOD
- Department Name
- Medical oncology department
- Principal Investigator Name
- Tsvetelina Kondzhova
- Principal Investigator Email
- mdkondzhova@gmail.com
- Contact Person Name
- Tsvetelina Kondzhova
- Contact Person Email
- mdkondzhova@gmail.com
- Site Name
- Medical Centre Futuremeds EOOD
- Department Name
- -
- Principal Investigator Name
- Nikolay Shopov
- Principal Investigator Email
- nikolay.shopov@futuremeds.bg
- Contact Person Name
- Nikolay Shopov
- Contact Person Email
- nikolay.shopov@futuremeds.bg
- Site Name
- Mbal Za Zhensko Zdrave Nadezhda OOD
- Department Name
- Clinic of medical oncology
- Principal Investigator Name
- Mila Petrova
- Principal Investigator Email
- milllapetrova@gmail.com
- Contact Person Name
- Mila Petrova
- Contact Person Email
- milllapetrova@gmail.com
- Site Name
- Specialized Hospital For Active Treatment Of Oncology Haskovo EOOD
- Department Name
- Department of medical oncology
- Principal Investigator Name
- Stoil Boychev
- Principal Investigator Email
- dr.stoil.boichev@gmail.com
- Contact Person Name
- Stoil Boychev
- Contact Person Email
- dr.stoil.boichev@gmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 09-12-2025
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 98
- Number Of Sites
- 6
- Number Of Participants
- 24
Sites
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Klinika nemocí plicních a tuberkulózy
- Principal Investigator Name
- Bohdan Kadlec
- Principal Investigator Email
- kadlec.bohdan@fnbrno.cz
- Contact Person Name
- Bohdan Kadlec
- Contact Person Email
- kadlec.bohdan@fnbrno.cz
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Onkologická klinika 2. LF UK a FN Motol
- Principal Investigator Name
- Tomas Buchler
- Principal Investigator Email
- tomas.buchler@fnmotol.cz
- Contact Person Name
- Tomas Buchler
- Contact Person Email
- tomas.buchler@fnmotol.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Klinika onkologie a radioterapie
- Principal Investigator Name
- Stanislav John
- Principal Investigator Email
- stanislav.john@fnhk.cz
- Contact Person Name
- Stanislav John
- Contact Person Email
- stanislav.john@fnhk.cz
- Site Name
- University Hospital Olomouc
- Department Name
- Onkologická klinika
- Principal Investigator Name
- Bohuslav Melichar
- Principal Investigator Email
- bohuslav.melichar@fnol.cz
- Contact Person Name
- Bohuslav Melichar
- Contact Person Email
- bohuslav.melichar@fnol.cz
- Site Name
- Multiscan s.r.o.
- Department Name
- Onkologie Nemocnice Hořovice
- Principal Investigator Name
- Martin Smakal
- Principal Investigator Email
- msmakal@gmail.com
- Contact Person Name
- Martin Smakal
- Contact Person Email
- msmakal@gmail.com
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Onkologická klinika, Fakultní poliklinika
- Principal Investigator Name
- Michal Vocka
- Principal Investigator Email
- michal.vocka@vfn.cz
- Contact Person Name
- Michal Vocka
- Contact Person Email
- michal.vocka@vfn.cz
France
- Earliest CTIS Part Ii Submission Date
- 13-01-2026
- Latest Decision Or Authorization Date
- 10-04-2026
- Processing Time Days
- 87
- Number Of Sites
- 6
- Number Of Participants
- 44
Sites
- Site Name
- Centre Regional Lutte Contre Le Cancer
- Department Name
- Medical oncology
- Principal Investigator Name
- Meher Ben Abdelghani
- Principal Investigator Email
- m.ben-badelghani@icans.eu
- Contact Person Name
- Meher Ben Abdelghani
- Contact Person Email
- m.ben-badelghani@icans.eu
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Medical oncology
- Principal Investigator Name
- Francois Goldwasser
- Principal Investigator Email
- francois.goldwasser@aphp.fr
- Contact Person Name
- Francois Goldwasser
- Contact Person Email
- francois.goldwasser@aphp.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Pamela Funk Debleds
- Principal Investigator Email
- pamela.funk-debleds@lyon.unicancer.fr
- Contact Person Name
- Pamela Funk Debleds
- Contact Person Email
- pamela.funk-debleds@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- oncology
- Principal Investigator Name
- Estelle Dhamelincourt
- Principal Investigator Email
- estelle.dhamelincourt@chu-brest.fr
- Contact Person Name
- Estelle Dhamelincourt
- Contact Person Email
- estelle.dhamelincourt@chu-brest.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Medical oncology
- Principal Investigator Name
- Guillaume Economos
- Principal Investigator Email
- guillaume.economos@chu-lyon.fr
- Contact Person Name
- Guillaume Economos
- Contact Person Email
- guillaume.economos@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- oncologie
- Principal Investigator Name
- Christophe Tournigand
- Principal Investigator Email
- christophe.tournigand@aphp.fr
- Contact Person Name
- Christophe Tournigand
- Contact Person Email
- christophe.tournigand@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 93
- Number Of Sites
- 10
- Number Of Participants
- 44
Sites
- Site Name
- Universitaetsmedizin Greifswald KöR
- Department Name
- Klinik und Poliklinik für Innere Medizin A
- Principal Investigator Name
- Frederick Roskoden
- Principal Investigator Email
- frederickCharles.Roskoden@med.uni-greifswald.de
- Contact Person Name
- Frederick Roskoden
- Contact Person Email
- frederickCharles.Roskoden@med.uni-greifswald.de
- Site Name
- Johanniter GmbH
- Department Name
- Internal Medicine Hematooncology
- Principal Investigator Name
- Yon-Dschun Ko
- Principal Investigator Email
- Yon-dschun.ko@bn.johanniter-kliniken.de
- Contact Person Name
- Yon-Dschun Ko
- Contact Person Email
- Yon-dschun.ko@bn.johanniter-kliniken.de
- Site Name
- Muenchen Klinik gGmbH
- Department Name
- Hematology and Oncology
- Principal Investigator Name
- Stefan Böck
- Principal Investigator Email
- stefan.boeck@muenchen-klinik.de
- Contact Person Name
- Stefan Böck
- Contact Person Email
- stefan.boeck@muenchen-klinik.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Dep.of Medicine 1-Gastroentero.,Pneumo.,and Endocrino.,Hector-Center for Nutrition,Exercise, Sports
- Principal Investigator Name
- Yurdagül Zopf
- Principal Investigator Email
- Yurdaguel.Zopf@uk-erlangen.de
- Contact Person Name
- Yurdagül Zopf
- Contact Person Email
- Yurdaguel.Zopf@uk-erlangen.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Dept. of Internal Medicine I, Hematology, Oncology and Stem Cell Transplantation
- Principal Investigator Name
- Christine Greil
- Principal Investigator Email
- christine.greil@uniklinik-freiburg.de
- Contact Person Name
- Christine Greil
- Contact Person Email
- christine.greil@uniklinik-freiburg.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Center of Tumor Diseases
- Principal Investigator Name
- Sergio Armando Zapata Bonilla
- Principal Investigator Email
- sergio.zapatabonilla@unimedizin-mainz.de
- Contact Person Name
- Sergio Armando Zapata Bonilla
- Contact Person Email
- sergio.zapatabonilla@unimedizin-mainz.de
- Site Name
- LungenClinic Grosshansdorf GmbH
- Department Name
- LungenClinic Großhansdorf GmbH
- Principal Investigator Name
- Barbara Storbeck
- Principal Investigator Email
- b.storbeck@lungenclinic.de
- Contact Person Name
- Barbara Storbeck
- Contact Person Email
- b.storbeck@lungenclinic.de
- Site Name
- Universitaetsklinikum Koeln AöR
- Department Name
- Department I of Internal Medicine
- Principal Investigator Name
- Thomas Zander
- Principal Investigator Email
- thomas.zander@uk-koeln.de
- Contact Person Name
- Thomas Zander
- Contact Person Email
- thomas.zander@uk-koeln.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Oncology
- Principal Investigator Name
- Martin Wermke
- Principal Investigator Email
- martin.wermke@uniklinikum-dresden.de
- Contact Person Name
- Martin Wermke
- Contact Person Email
- martin.wermke@uniklinikum-dresden.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Interdisciplinary Study Center with Early Clinical Trial Unit
- Principal Investigator Name
- Maria-Elisabeth Goebeler
- Principal Investigator Email
- Goebeler_m@ukw.de
- Contact Person Name
- Maria-Elisabeth Goebeler
- Contact Person Email
- Goebeler_m@ukw.de
Spain
- Earliest CTIS Part Ii Submission Date
- 28-10-2025
- Latest Decision Or Authorization Date
- 18-02-2026
- Processing Time Days
- 112
- Number Of Sites
- 7
- Number Of Participants
- 48
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Imanol Martinez Salas
- Principal Investigator Email
- imanol.martinez@quironsalud.es
- Contact Person Name
- Imanol Martinez Salas
- Contact Person Email
- imanol.martinez@quironsalud.es
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Medical Oncology
- Principal Investigator Name
- Mariano Provencio Pulla
- Principal Investigator Email
- mprovenciop@gmail.com
- Contact Person Name
- Mariano Provencio Pulla
- Contact Person Email
- mprovenciop@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Principal Investigator Name
- Teresa Macarulla Mercade
- Principal Investigator Email
- macarulla@clinic.cat
- Contact Person Name
- Teresa Macarulla Mercade
- Contact Person Email
- macarulla@clinic.cat
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Oncology
- Principal Investigator Name
- Rosa Querol Niñerola
- Principal Investigator Email
- rquerol@tauli.cat
- Contact Person Name
- Rosa Querol Niñerola
- Contact Person Email
- rquerol@tauli.cat
- Site Name
- Area Sanitaria Da Coruna E Cee
- Department Name
- Medical Oncology
- Principal Investigator Name
- Beatriz Alonso de Castro
- Principal Investigator Email
- beatriz.alonso.de.castro@sergas.es
- Contact Person Name
- Beatriz Alonso de Castro
- Contact Person Email
- beatriz.alonso.de.castro@sergas.es
- Site Name
- Futuremeds Spain S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Delia Cortes Guiral
- Principal Investigator Email
- delia.cortes@futuremeds.com
- Contact Person Name
- Delia Cortes Guiral
- Contact Person Email
- delia.cortes@futuremeds.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Mª Elena Elez Fernandez
- Principal Investigator Email
- meelez@vhio.net
- Contact Person Name
- Mª Elena Elez Fernandez
- Contact Person Email
- meelez@vhio.net
Norway
- Earliest CTIS Part Ii Submission Date
- 23-01-2026
- Latest Decision Or Authorization Date
- 18-02-2026
- Processing Time Days
- 95
- Number Of Sites
- 5
- Number Of Participants
- 25
Sites
- Site Name
- Sorlandet Sykehus HF
- Department Name
- Sørlandet Hospital, Kristiansand
- Principal Investigator Name
- Linn Kruse Tetlie
- Principal Investigator Email
- Linn.Kruse@sshf.no
- Contact Person Name
- Linn Kruse Tetlie
- Contact Person Email
- Linn.Kruse@sshf.no
- Site Name
- Akershus University Hospital
- Department Name
- Akershus University Hospital
- Principal Investigator Name
- Åsa Dahle Smith
- Principal Investigator Email
- Asa.Dahle.Smith@ahus.no
- Contact Person Name
- Åsa Dahle Smith
- Contact Person Email
- Asa.Dahle.Smith@ahus.no
- Site Name
- Helse Bergen HF
- Department Name
- Cancer Clinic
- Principal Investigator Name
- Ane Rømmen do Carmo
- Principal Investigator Email
- ane.rommen.do.carmo@helse-bergen.no
- Contact Person Name
- Ane Rømmen do Carmo
- Contact Person Email
- ane.rommen.do.carmo@helse-bergen.no
- Site Name
- St. Olavs Hospital HF
- Department Name
- Cancer Clinic
- Principal Investigator Name
- Ola Magne Vagnildhaug
- Principal Investigator Email
- ola.m.vagnildhaug@ntnu.no
- Contact Person Name
- Ola Magne Vagnildhaug
- Contact Person Email
- ola.m.vagnildhaug@ntnu.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Oncology
- Principal Investigator Name
- Tormod Kyrre Guren
- Principal Investigator Email
- uxtour@ous-hf.no
- Contact Person Name
- Tormod Kyrre Guren
- Contact Person Email
- uxtour@ous-hf.no
Poland
- Earliest CTIS Part Ii Submission Date
- 09-01-2026
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 101
- Number Of Sites
- 13
- Number Of Participants
- 80
Sites
- Site Name
- Futuremeds Sp. z o.o. (Warsaw)
- Department Name
- FutureMeds Warszawa Targówek
- Principal Investigator Name
- Krzysztof Ostaszewski
- Principal Investigator Email
- feasibility@futuremeds.com
- Contact Person Name
- Krzysztof Ostaszewski
- Contact Person Email
- feasibility@futuremeds.com
- Site Name
- Futuremeds Sp. z o.o. (Lodz)
- Department Name
- FutureMeds Łódź
- Principal Investigator Name
- Łukasz Matczak
- Principal Investigator Email
- lukasz.matczak@futuremeds.com
- Contact Person Name
- Łukasz Matczak
- Contact Person Email
- lukasz.matczak@futuremeds.com
- Site Name
- Pratia S.A. (Cracow)
- Department Name
- Pratia MCM Kraków
- Principal Investigator Name
- Joanna Seredyńska
- Principal Investigator Email
- jseredynska@pratia.pl
- Contact Person Name
- Joanna Seredyńska
- Contact Person Email
- jseredynska@pratia.pl
- Site Name
- Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
- Department Name
- Oddział Onkologii Klinicznej z Pododdziałem Dziennym
- Principal Investigator Name
- Anna Kowalczyk-Tekiela
- Principal Investigator Email
- badaniakliniczne@rydygierkrakow.pl
- Contact Person Name
- Anna Kowalczyk-Tekiela
- Contact Person Email
- badaniakliniczne@rydygierkrakow.pl
- Site Name
- Regionalny Szpital Specjalistyczny Im. Dr. Wladyslawa Bieganskiego
- Department Name
- Poradnia Onkologiczna
- Principal Investigator Name
- Urszula Sadowska
- Principal Investigator Email
- ula@stolcad.pl
- Contact Person Name
- Urszula Sadowska
- Contact Person Email
- ula@stolcad.pl
- Site Name
- Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
- Department Name
- Oddział Onkologii Klinicznej Chemioterapii
- Principal Investigator Name
- Katarzyna Woźniak
- Principal Investigator Email
- poczta@spzoz.jgora.pl
- Contact Person Name
- Katarzyna Woźniak
- Contact Person Email
- poczta@spzoz.jgora.pl
- Site Name
- Pratia S.A. (Wroclaw)
- Department Name
- Pratia Onkologia Wrocław
- Principal Investigator Name
- Jacek Calik
- Principal Investigator Email
- malgorzata.gerjatowicz-osmanska@pratia.com
- Contact Person Name
- Jacek Calik
- Contact Person Email
- malgorzata.gerjatowicz-osmanska@pratia.com
- Site Name
- Ms Pneumed Janusz Milanowski Katarzyna Szmygin-Milanowska sp.j.
- Department Name
- MS Pneumed
- Principal Investigator Name
- Janusz Milanowski
- Principal Investigator Email
- mspneumed@gmail.com
- Contact Person Name
- Janusz Milanowski
- Contact Person Email
- mspneumed@gmail.com
- Site Name
- Futuremeds Sp. z o.o. (Cracow Mikolaja Kopernika)
- Department Name
- FutureMeds Kraków
- Principal Investigator Name
- Michał Parkitny
- Principal Investigator Email
- malgorzata.herrera@futuremeds.com
- Contact Person Name
- Michał Parkitny
- Contact Person Email
- malgorzata.herrera@futuremeds.com
- Site Name
- Futuremeds Sp. z o.o. (Wroclaw Legnicka)
- Department Name
- FutureMeds Wrocław
- Principal Investigator Name
- Łukasz Hajac
- Principal Investigator Email
- lukasz.hajac@futuremeds.com
- Contact Person Name
- Łukasz Hajac
- Contact Person Email
- lukasz.hajac@futuremeds.com
- Site Name
- Pratia Hematologia Sp. z o.o.
- Department Name
- Poradnia Onkologiczna
- Principal Investigator Name
- Agata Kachel-Flis
- Principal Investigator Email
- agata.kachel-flis@pratia.com
- Contact Person Name
- Agata Kachel-Flis
- Contact Person Email
- agata.kachel-flis@pratia.com
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddział Chorób Rozrostowych
- Principal Investigator Name
- Maja Lisik-Habib
- Principal Investigator Email
- de.liber-grabowska@kopernik.lodz.pl
- Contact Person Name
- Maja Lisik-Habib
- Contact Person Email
- de.liber-grabowska@kopernik.lodz.pl
- Site Name
- Jagiellonskie Centrum Innowacji Sp. z o.o.
- Department Name
- Poradnia Onkologiczna
- Principal Investigator Name
- Mirosława Püsküllüoglu
- Principal Investigator Email
- monika.patola.dzierwa@jci.pl
- Contact Person Name
- Mirosława Püsküllüoglu
- Contact Person Email
- monika.patola.dzierwa@jci.pl
Romania
- Earliest CTIS Part Ii Submission Date
- 28-10-2025
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 188
- Number Of Sites
- 8
- Number Of Participants
- 42
Sites
- Site Name
- Oncolab S.R.L.
- Department Name
- Oncologie
- Principal Investigator Name
- Cristian-Virgil Lungulescu
- Principal Investigator Email
- dan.lungulescu@yahoo.com
- Contact Person Name
- Cristian-Virgil Lungulescu
- Contact Person Email
- dan.lungulescu@yahoo.com
- Site Name
- Ovidius Clinical Hospital S.R.L.
- Department Name
- Oncologie, Hematologie
- Principal Investigator Name
- Laura Mazilu
- Principal Investigator Email
- office@ovidius-ch.ro
- Contact Person Name
- Laura Mazilu
- Contact Person Email
- office@ovidius-ch.ro
- Site Name
- Pelican Impex S.R.L.
- Department Name
- Oncologie Medicala
- Principal Investigator Name
- Ioana-Adriana Ciurescu
- Principal Investigator Email
- ioana_covaciu@yahoo.com
- Contact Person Name
- Ioana-Adriana Ciurescu
- Contact Person Email
- ioana_covaciu@yahoo.com
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Oncologie Medicala
- Principal Investigator Name
- Michael Schenker
- Principal Investigator Email
- mike_schenker@yahoo.com
- Contact Person Name
- Michael Schenker
- Contact Person Email
- mike_schenker@yahoo.com
- Site Name
- Gral Medical S.R.L.
- Department Name
- Oncologie Medicala
- Principal Investigator Name
- Adela-Luiza Chirila
- Principal Investigator Email
- mariacristina.bradea-teodorescu@psi-cro.com
- Contact Person Name
- Adela-Luiza Chirila
- Contact Person Email
- mariacristina.bradea-teodorescu@psi-cro.com
- Site Name
- Futuremeds S.R.L. (Galati)
- Department Name
- Oncologie
- Principal Investigator Name
- Cosmin Boldeanu
- Principal Investigator Email
- sabin.alexe@futuremeds.com
- Contact Person Name
- Cosmin Boldeanu
- Contact Person Email
- sabin.alexe@futuremeds.com
- Site Name
- Oncomed S.R.L.
- Department Name
- Oncologie Medicala
- Principal Investigator Name
- Daniela Elvira Sirbu
- Principal Investigator Email
- valeriu.boruga@oncohelp.ro
- Contact Person Name
- Daniela Elvira Sirbu
- Contact Person Email
- valeriu.boruga@oncohelp.ro
- Site Name
- Futuremeds S.R.L. (Brasov)
- Department Name
- Oncologie Medicala
- Principal Investigator Name
- Florentina Pescaru
- Principal Investigator Email
- sabin.alexe@futuremeds.com
- Contact Person Name
- Florentina Pescaru
- Contact Person Email
- sabin.alexe@futuremeds.com
Sponsor
Primary sponsor
- Full Name
- CatalYm GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Amicus Clinical Development Limited
- Responsibilities
- code:5
- Name
- Medpace Finland Oy
- Responsibilities
- code:1; code:12; code:13; code:2; code:5
- Name
- Metronomia Clinical Research GmbH
- Responsibilities
- code:6
- Name
- Suvoda LLC
- Responsibilities
- code:3
- Name
- Primevigilance Limited
- Responsibilities
- code:8 (pharmacovigilance)
Third parties
- {"country":"Germany","full_name":"Mlm Medical Labs GmbH","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Amicus Clinical Development Limited","duties_or_roles":"code:5","organisation_type":"Pharmaceutical company"}
- {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"code:1; code:12; code:13; code:2; code:5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Bulgaria","full_name":"August Research OOD","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Actigraph LLC","duties_or_roles":"code:15 (wearables supplier)","organisation_type":"Pharmaceutical company"}
- {"country":"Lithuania","full_name":"Biomapas UAB","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"code:8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Metabolon Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"European Organisation For Research And Treatment Of Cancer","duties_or_roles":"code:15 (Patient Reported Outcomes licensor)","organisation_type":"Patient organisation/association"}
- {"country":"France","full_name":"Eurofins Adme Bioanalyses","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Metronomia Clinical Research GmbH","duties_or_roles":"code:6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fisher Bioservices Inc.","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"FACIT.Org Inc.","duties_or_roles":"code:15 (Patient Reported Outcomes licensor)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Alderley Analytical Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Median Technologies","duties_or_roles":"code:15 (Central reading of CT scans)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Visugromab (CTL-002)
- Active Substance
- VISUGROMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Investigational product (for trial use)
- Investigational Product Name
- Placebo matching Visugromab (CTL-002)
- Modality
- Other
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