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
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
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
Contact Person Name
Frederick Roskoden
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
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
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
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
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
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
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
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
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
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
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
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
Contact Person Name
Adela-Luiza Chirila
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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