Clinical trial • Phase I/II • Oncology

GSK5764227 for Gastrointestinal neoplasms|Colorectal cancer|Pancreatic adenocarcinoma

Phase I/II trial of GSK5764227 for Gastrointestinal neoplasms|Colorectal cancer|Pancreatic adenocarcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Gastrointestinal neoplasms|Colorectal cancer|Pancreatic adenocarcinoma
Trial Stage
Phase I/II
Drug Modality
Other antibody

Key dates

Initial CTIS Submission Date
09-05-2025
First CTIS Authorization Date
27-08-2025

Trial design

Randomised, open-label, none/not specified-controlled, adaptive Phase I/II trial in Belgium, Italy, Norway and others.

Randomised
Yes
Open Label
Yes
Comparator
None/Not specified
Adaptive
True, dose evaluation across cohorts including two Q3W and two Q2W dosing schedules in Part 1A and cohort-based evaluation (dose-finding elements implied by Part 1 design)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
140

Eligibility

Recruits 140 No vulnerable population selected. Participants must be at least 18 years old (or legal age of consent in the jurisdiction) and provide informed consent; there is no assent/parental consent described for minors because minors are excluded..

Vulnerable Population
No vulnerable population selected. Participants must be at least 18 years old (or legal age of consent in the jurisdiction) and provide informed consent; there is no assent/parental consent described for minors because minors are excluded.

Inclusion criteria

  • {"criterion_text":"- All cohorts: Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place years of age at the time of signing the ICF\n- Has adequate organ function as defined in the protocol\n- Cohort A (CRC) Part 1A Participants only: Has histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by WHO classification).\n- Cohort A (CRC) Part 1A Participants only: Must have received 1-2 lines of systemic treatment for advanced CRC including the following: a fluoropyrimidine, oxaliplatin and/or irinotecan, an anti-VEGF monoclonal antibody and/or an anti-EGFR monoclonal antibody, if the approved biologic therapy(ies) is available.\n- Cohort A (CRC) Part 1A Participants only: Must provide tumor tissue from a newly obtained fresh biopsy or an archival tumor tissue.\n- Cohort B (PDAC) Part 1B Participants only: Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification).\n- Cohort B (PDAC) Part 1B Participants only: Must have received 1 and no more than 1 line of therapy for advanced PDAC, with documented progression.\n- Cohort B (PDAC) Part 1B Participants only: Should provide tumor tissue at screening, where available or medically feasible.\n- All cohorts: Has at least 1 target lesion per RECIST 1.1\n- Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before randomization (CRC-A and CRC-B) or before first dose of study intervention (Cohort B)"}

Exclusion criteria

  • {"criterion_text":"- Has had any major surgery within 28 days prior to randomization (CRC-A and CRC-B) or before first dose of study intervention (Cohort B)\n- Has severe, uncontrolled or active cardiovascular disorders\n- Has serious or poorly controlled hypertension\n- Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.\n- Has untreated brain or CNS metastases or brain/CNS metastases that have progressed.\n- Principal Exclusion Criteria Has current active pneumonitis or any history of pneumonitis requiring steroids or immunomodulatory treatment within 90 days of planned randomization (CRC-A and CRC-B) or planned first dose of study intervention (Cohort B) or any history of drug-induced pneumonitis.\n- Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to Grade 1 or to the baseline status preceding prior therapy\n- Has received any prior therapy with an ADC with a TOPO1-inhibitor payload"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Confirmed ORR, defined as the proportion of participants who have achieved BOR of confirmed CR or PR as assessed by investigator, according to RECIST 1.1.","definition_or_measurement_approach":"Defined as the proportion of participants who have achieved BOR of confirmed CR or PR as assessed by investigator according to RECIST 1.1."}

Recruitment

Planned Sample Size
140
Recruitment Window Months
34
Consent Approach
Written informed consent is required from each participant (participants must be ≥18 or legal age of consent). Multiple country-specific informed consent forms are provided (numerous L1_ICF documents listed for different countries and languages) including pregnancy-specific information and optional future research/genetic research appendices. No assent/parental consent procedures described (vulnerable populations not selected).

Geography

Total Number Of Sites
59
Total Number Of Participants
176

Belgium

Earliest CTIS Part Ii Submission Date
06-08-2025
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
260
Number Of Sites
4
Number Of Participants
19

Sites

Site Name
Algemeen Ziekenhuis Delta
Department Name
Digestive Oncology
Principal Investigator Name
Sofie De Meulder
Principal Investigator Email
secr.mdl@azdelta.be
Contact Person Name
Sofie De Meulder
Contact Person Email
secr.mdl@azdelta.be
Site Name
UZ Leuven
Department Name
Digestive Oncology
Principal Investigator Name
Gertjan Rasschaert
Principal Investigator Email
secretariaatmdl@uzleuven.be
Contact Person Name
Gertjan Rasschaert
Contact Person Email
secretariaatmdl@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Digestive Oncology
Principal Investigator Name
Marc Van den Eynde
Principal Investigator Email
marc.vandeneynde@saintluc.uclouvain.be
Contact Person Name
Marc Van den Eynde
Site Name
Imelda
Department Name
Digestive Oncology
Principal Investigator Name
Pieter-Jan Cuyle
Principal Investigator Email
Pieter-Jan.Cuyle@imelda.be
Contact Person Name
Pieter-Jan Cuyle
Contact Person Email
Pieter-Jan.Cuyle@imelda.be

Italy

Earliest CTIS Part Ii Submission Date
29-05-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
330
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
S.C. Oncologia Falk
Principal Investigator Name
Salvatore Siena
Principal Investigator Email
salvatore.siena@ospedaleniguarda.it
Contact Person Name
Salvatore Siena
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S.C. Oncologia Medica 1
Principal Investigator Name
Filippo Pietrantonio
Principal Investigator Email
filippo.pietrantonio@istitutotumori.mi.it
Contact Person Name
Filippo Pietrantonio
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Unità di Fase 1
Principal Investigator Name
Gennaro Daniele
Principal Investigator Email
gennaro.daniele@policlinicogemelli.it
Contact Person Name
Gennaro Daniele
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci
Principal Investigator Name
Chiara Cremolini
Principal Investigator Email
chiaracremolini@gmail.com
Contact Person Name
Chiara Cremolini
Contact Person Email
chiaracremolini@gmail.com

Norway

Earliest CTIS Part Ii Submission Date
04-08-2025
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
268
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Oslo University Hospital HF
Department Name
Onkologisk avdeling
Principal Investigator Name
Jørgen Smeby
Principal Investigator Email
joesme@ous-hf.no
Contact Person Name
Jørgen Smeby
Contact Person Email
joesme@ous-hf.no
Site Name
Helse Stavanger HF
Department Name
Avdeling for Blod og Kreftsykdommer
Principal Investigator Name
Herish Garresori
Principal Investigator Email
firstname.lastname@sus.no
Contact Person Name
Herish Garresori
Contact Person Email
firstname.lastname@sus.no
Site Name
Akershus University Hospital
Department Name
Avdeling for Onkologi, Nye Nord, Nordbyhagen
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

Finland

Earliest CTIS Part Ii Submission Date
04-08-2025
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
266
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Tampere University Hospital
Department Name
FONK (oncological clinical trial unit)
Principal Investigator Name
Pia Österlund
Principal Investigator Email
etunimi.sukunimi@pirha.fi
Contact Person Name
Pia Österlund
Contact Person Email
etunimi.sukunimi@pirha.fi
Site Name
Docrates Oy
Department Name
Docrates Cancer Center
Principal Investigator Name
Tuomo Alanko
Principal Investigator Email
etunimi.sukunimi@docrates.com
Contact Person Name
Tuomo Alanko
Contact Person Email
etunimi.sukunimi@docrates.com
Site Name
HUS-Yhtymae
Department Name
Comprehensive Cancer Center
Principal Investigator Name
Sari Jäämaa
Principal Investigator Email
etunimi.sukunimi@hus.fi
Contact Person Name
Sari Jäämaa
Contact Person Email
etunimi.sukunimi@hus.fi
Site Name
Pohjois-Savon hyvinvointialue
Department Name
Oncology
Principal Investigator Name
Okko Kääriäinen
Principal Investigator Email
etunimi.sukunimi@pshyvinvointialue.fi
Contact Person Name
Okko Kääriäinen

Poland

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
263
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Krakow site)
Department Name
Oddział w Krakowie Klinika Onkologii Klinicznej
Principal Investigator Name
Marek Ziobro
Principal Investigator Email
marek.ziobro@krakow.nio.gov.pl
Contact Person Name
Marek Ziobro
Contact Person Email
marek.ziobro@krakow.nio.gov.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
mariusz.kwiatkowski@swk.med.pl
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
mariusz.kwiatkowski@swk.med.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw site)
Department Name
Klinika Onkologii i Radioterapii
Principal Investigator Name
Lucjan Wyrwicz
Principal Investigator Email
lucjan.wyrwicz@nio.gov.pl
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
lucjan.wyrwicz@nio.gov.pl
Site Name
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Department Name
Oddzial Onkologii Klinicznej
Principal Investigator Name
Cezary Szczylik
Principal Investigator Email
Cezary.szczylik@ecz-otwock.pl
Contact Person Name
Cezary Szczylik
Contact Person Email
Cezary.szczylik@ecz-otwock.pl
Site Name
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Department Name
Oddzial Onkologii Klinicznej
Principal Investigator Name
Joanna Kiszka
Principal Investigator Email
kiszka_joanna@wp.pl
Contact Person Name
Joanna Kiszka
Contact Person Email
kiszka_joanna@wp.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Centrum Wsparcia Badan Klinicznych
Principal Investigator Name
Wojciech Solarek
Principal Investigator Email
wsolarek@wim.mil.pl
Contact Person Name
Wojciech Solarek
Contact Person Email
wsolarek@wim.mil.pl

Netherlands

Earliest CTIS Part Ii Submission Date
08-08-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
259
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Netherlands Cancer Institute
Department Name
Oncologie
Principal Investigator Name
Marieke Vollebergh
Principal Investigator Email
m.vollebergh@nki.nl
Contact Person Name
Marieke Vollebergh
Contact Person Email
m.vollebergh@nki.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Medische oncologie
Principal Investigator Name
Robert Jan Kwakman
Principal Investigator Email
J.J.M.Kwakman-3@umcutrecht.nl
Contact Person Name
Robert Jan Kwakman
Contact Person Email
J.J.M.Kwakman-3@umcutrecht.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Oncologie
Principal Investigator Name
Henk Verheul
Principal Investigator Email
h.verheul@erasmusmc.nl
Contact Person Name
Henk Verheul
Contact Person Email
h.verheul@erasmusmc.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Oncologie
Principal Investigator Name
Liselot Valkenburg-Van Iersel
Principal Investigator Email
liselot.van.iersel@mumc.nl
Contact Person Name
Liselot Valkenburg-Van Iersel
Contact Person Email
liselot.van.iersel@mumc.nl

Sweden

Earliest CTIS Part Ii Submission Date
04-08-2025
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
267
Number Of Sites
5
Number Of Participants
9

Sites

Site Name
Soedersjukhuset AB
Department Name
Kliniska Forskningsenheten Onkologi kliniken
Principal Investigator Name
Virginia Alvariza
Principal Investigator Email
firstname.lastname@regionstockholm.se
Contact Person Name
Virginia Alvariza
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
SU/Jubileumskliniken
Principal Investigator Name
Leif Klint
Principal Investigator Email
leif.klint@vgregion.se
Contact Person Name
Leif Klint
Contact Person Email
leif.klint@vgregion.se
Site Name
Uppsala University Hospital
Department Name
KFUE – Kliniska forsknings- och utvecklingsenheten Verksamhetsområde Blod- och Tumörsjukdomar
Principal Investigator Name
Simon Pahnke
Principal Investigator Email
firstname.lastname@akademiska.se
Contact Person Name
Simon Pahnke
Site Name
Karolinska University Hospital
Department Name
Karolinska Comprehensive Cancer Center ME Center for Clinical Cancer Studies Tema Cancer|Karolinska
Principal Investigator Name
Maximilian Kordes
Principal Investigator Email
firstname.lastname@regionstockholm.se
Contact Person Name
Maximilian Kordes
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO hematologi, onkologi och strålningsfysik
Principal Investigator Name
Jakob Eberhard
Principal Investigator Email
jakob.eberhard@med.lu.se
Contact Person Name
Jakob Eberhard
Contact Person Email
jakob.eberhard@med.lu.se

France

Earliest CTIS Part Ii Submission Date
24-07-2025
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
273
Number Of Sites
9
Number Of Participants
25

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hotel Dieu-Oncology medical department
Principal Investigator Name
Yann Touchefeu
Principal Investigator Email
yann.touchefeu@chu-nantes.fr
Contact Person Name
Yann Touchefeu
Contact Person Email
yann.touchefeu@chu-nantes.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hôpital Saint-Louis - Service de Gastro-Entérologie et Oncologie Digestive
Principal Investigator Name
Thomas Aparicio
Principal Investigator Email
thomas.aparicio@aphp.fr
Contact Person Name
Thomas Aparicio
Contact Person Email
thomas.aparicio@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hôpital Saint Antoine - Service d'Oncologie Médicale
Principal Investigator Name
Thierry Andre
Principal Investigator Email
thierry.andre@aphp.fr
Contact Person Name
Thierry Andre
Contact Person Email
thierry.andre@aphp.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service d'Hépato-Gastro-Entérologie
Principal Investigator Name
David Tougeron
Principal Investigator Email
david.tougeron@chu-poitiers.fr
Contact Person Name
David Tougeron
Contact Person Email
david.tougeron@chu-poitiers.fr
Site Name
Institut Gustave Roussy
Department Name
Service de Gastro-Entérologie
Principal Investigator Name
Michel Ducreux
Principal Investigator Email
michel.ducreux@gustaveroussy.fr
Contact Person Name
Michel Ducreux
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Medical Oncology
Principal Investigator Name
Julien Edeline
Principal Investigator Email
j.edeline@rennes.unicancer.fr
Contact Person Name
Julien Edeline
Contact Person Email
j.edeline@rennes.unicancer.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hopital Européen Georges Pompidou - Service Oncologie Gastro-Intestinale
Principal Investigator Name
Julien Taieb
Principal Investigator Email
julien.taieb@aphp.fr
Contact Person Name
Julien Taieb
Contact Person Email
julien.taieb@aphp.fr
Site Name
Institut Paoli Calmettes
Department Name
Service d'Oncologie Médicale 1
Principal Investigator Name
Emmanuel Mitry
Principal Investigator Email
mitryje@ipc.unicancer.fr
Contact Person Name
Emmanuel Mitry
Contact Person Email
mitryje@ipc.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Hopital Francois Mitterrand - Service d'Hépato-Gastro-Entérologie
Principal Investigator Name
Côme Lepage
Principal Investigator Email
come.lepage@chu-dijon.fr
Contact Person Name
Côme Lepage
Contact Person Email
come.lepage@chu-dijon.fr

Germany

Earliest CTIS Part Ii Submission Date
12-08-2025
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
258
Number Of Sites
9
Number Of Participants
25

Sites

Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
GI-Onkologie Klinik für Gastroenterologie, Hepatologie und Infektiologie
Principal Investigator Name
Christoph Roderburg
Principal Investigator Email
Christoph.Roderburg@med.uni-duesseldorf.de
Contact Person Name
Christoph Roderburg
Site Name
Technische Universitaet Dresden
Department Name
Universitätsklinikum Carl Gustav Carus Dresden Medizinische Klinik I
Principal Investigator Name
Gunnar Folprecht
Principal Investigator Email
gunnar.folprecht@uniklinikum-dresden.de
Contact Person Name
Gunnar Folprecht
Site Name
Muenchen Klinik gGmbH
Department Name
Klinik für Hämatologie und Onkologie, Studienbüro Neuperlach / Harlaching
Principal Investigator Name
Stefan Böck
Principal Investigator Email
stefan.boeck@muenchen-klinik.de
Contact Person Name
Stefan Böck
Site Name
Katholisches Klinikum Bochum gGmbH
Principal Investigator Name
Anke Reinacher-Schick
Principal Investigator Email
anke.reinacher@rub.de
Contact Person Name
Anke Reinacher-Schick
Contact Person Email
anke.reinacher@rub.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Hämatologie, Onkologie und Tumorimmunologie CVK
Principal Investigator Name
Dominik Modest
Principal Investigator Email
dominik.modest@charite.de
Contact Person Name
Dominik Modest
Contact Person Email
dominik.modest@charite.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
I. Medizinische Klinik und Poliklinik
Principal Investigator Name
Markus Möhler
Principal Investigator Email
markus.moehler@unimedizin-mainz.de
Contact Person Name
Markus Möhler
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik f Innere Medizin I Gastroenterologie, Endokrinologie, Nephrologie, Ernährung, Stoffwechs
Principal Investigator Name
Thomas Seufferlein
Principal Investigator Email
thomas.seufferlein@uniklinik-ulm.de
Contact Person Name
Thomas Seufferlein
Site Name
Luebecker Onkologische Schwerpunktpraxis
Principal Investigator Name
Jens Kisro
Principal Investigator Email
jens.kisro@t-online.de
Contact Person Name
Jens Kisro
Contact Person Email
jens.kisro@t-online.de
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch-Onkologische Forschung (IKF)
Principal Investigator Name
Thorsten Oliver Götze
Principal Investigator Email
goetze.thorsten@khnw.de
Contact Person Name
Thorsten Oliver Götze
Contact Person Email
goetze.thorsten@khnw.de

Spain

Earliest CTIS Part Ii Submission Date
06-08-2025
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
170
Number Of Sites
11
Number Of Participants
24

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncología
Principal Investigator Name
Iñigo Martínez Delfrade
Principal Investigator Email
imdelfrade@salud.madrid.org
Contact Person Name
Iñigo Martínez Delfrade
Contact Person Email
imdelfrade@salud.madrid.org
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncología
Principal Investigator Name
David Páez López-Bravo
Principal Investigator Email
dpaez@santpau.cat
Contact Person Name
David Páez López-Bravo
Contact Person Email
dpaez@santpau.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncología
Principal Investigator Name
María del Carmen Riesco Martínez
Principal Investigator Email
criesco@salud.madrid.org
Contact Person Name
María del Carmen Riesco Martínez
Contact Person Email
criesco@salud.madrid.org
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncología
Principal Investigator Name
Paula Jiménez Fonseca
Principal Investigator Email
palucaji@hotmail.com
Contact Person Name
Paula Jiménez Fonseca
Contact Person Email
palucaji@hotmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncología
Principal Investigator Name
Carlos López López
Principal Investigator Email
carlos.lopez@scsalud.es
Contact Person Name
Carlos López López
Contact Person Email
carlos.lopez@scsalud.es
Site Name
Hospital Universitario De Navarra
Department Name
Oncología
Principal Investigator Name
Ruth Vera García
Principal Investigator Email
ruth.vera.garcia@cfnavarra.es
Contact Person Name
Ruth Vera García
Contact Person Email
ruth.vera.garcia@cfnavarra.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncología
Principal Investigator Name
Lourdes Gutiérrez Sanz
Principal Investigator Email
lourdes.gutierrez@salud.madrid.org
Contact Person Name
Lourdes Gutiérrez Sanz
Site Name
Hospital Clinic De Barcelona
Department Name
Oncología
Principal Investigator Name
Joan Maurel Santasusana
Principal Investigator Email
JMAUREL@clinic.cat
Contact Person Name
Joan Maurel Santasusana
Contact Person Email
JMAUREL@clinic.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología
Principal Investigator Name
Elena Élez Fernández
Principal Investigator Email
meelez@vhio.net
Contact Person Name
Elena Élez Fernández
Contact Person Email
meelez@vhio.net
Site Name
Hospital Universitario Miguel Servet
Department Name
Oncología
Principal Investigator Name
Vicente Alonso Orduña
Principal Investigator Email
valonsoo@salud.aragon.es
Contact Person Name
Vicente Alonso Orduña
Contact Person Email
valonsoo@salud.aragon.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncología
Principal Investigator Name
Pilar García Alfonso
Principal Investigator Email
pgarcaalfonso@gmail.com
Contact Person Name
Pilar García Alfonso
Contact Person Email
pgarcaalfonso@gmail.com

Sponsor

Primary sponsor

Full Name
Glaxosmithkline Research & Development Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Contract research organisations

Name
Sermes CRO
Responsibilities
patient fee reimbursement
Name
Iqvia Rds Inc.
Responsibilities
Clinical Outcome assessment provider
Name
Bioclinica Inc.
Responsibilities
Imaging data collection

Third parties

  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long term sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging data collection","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"Clinical Outcome assessment provider","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code:4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long term sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"patient fee reimbursement","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"ZALARIS Deutschland GmbH","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Poland","full_name":"Let Me Pay Sp. z o.o.","duties_or_roles":"Patients' costs reimbursement management","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Primera Analytical Solutions Corp.","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"medicine product destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"Auxiliary material provision","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Clinops Tomasz Lusawa","duties_or_roles":"Medical equipment rental","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient travel concierge service","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Teckro Limited","duties_or_roles":"Site staff engagement","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"F-M Richard Et Associes","duties_or_roles":"Reimbursement of patient fees","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
GSK5764227
Active Substance
GSK5764227
Modality
Other antibody
Routes Of Administration
Intravenous
Route
Intravenous
Combination Treatment
Yes

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