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
- Contact Person Email
- marc.vandeneynde@saintluc.uclouvain.be
- 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
- Contact Person Email
- salvatore.siena@ospedaleniguarda.it
- 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
- Contact Person Email
- filippo.pietrantonio@istitutotumori.mi.it
- 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
- Contact Person Email
- gennaro.daniele@policlinicogemelli.it
- 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
- Contact Person Email
- etunimi.sukunimi@pshyvinvointialue.fi
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
- Contact Person Email
- firstname.lastname@regionstockholm.se
- 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
- Contact Person Email
- firstname.lastname@akademiska.se
- 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
- Contact Person Email
- firstname.lastname@regionstockholm.se
- 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
- Contact Person Email
- michel.ducreux@gustaveroussy.fr
- 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
- Contact Person Email
- Christoph.Roderburg@med.uni-duesseldorf.de
- 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
- Contact Person Email
- gunnar.folprecht@uniklinikum-dresden.de
- 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
- Contact Person Email
- stefan.boeck@muenchen-klinik.de
- 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
- Contact Person Email
- markus.moehler@unimedizin-mainz.de
- 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
- Contact Person Email
- thomas.seufferlein@uniklinik-ulm.de
- 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
- Contact Person Email
- lourdes.gutierrez@salud.madrid.org
- 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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