Clinical trial • Phase I/II • Oncology

GSK5733584 for Advanced solid tumors | Gynecological cancer

Phase I/II trial of GSK5733584 for Advanced solid tumors | Gynecological cancer. Randomised, open-label, adaptive. 175 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced solid tumors | Gynecological cancer
Trial Stage
Phase I/II
Drug Modality
ADC|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
13-01-2025
First CTIS Authorization Date
02-05-2025

Trial design

Randomised, open-label, adaptive Phase I/II trial in Poland, Spain, Belgium and others.

Randomised
Yes
Open Label
Yes
Adaptive
True, Part A is a dose exploration (dose-escalation) to determine Recommended Phase 2 Dose(s) with evaluation of dose-limiting toxicities (DLTs) and safety per dose level; Part B is a dose expansion evaluating clinical activity. Interim safety/PK/immunogenicity assessments inform dose decisions.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
175

Eligibility

Recruits 175 Vulnerable populations are not selected for inclusion. Participants must be 18 years of age inclusive or older (or the legal age of consent in the jurisdiction), and consent is to be provided by the participant (no pediatric assent procedures). IsVulnerablePopulationSelected is false in the trial record; consent materials (ICFs) are provided for adult participants and in multiple language versions..

Pregnancy Exclusion
Is pregnant or breastfeeding
Vulnerable Population
Vulnerable populations are not selected for inclusion. Participants must be 18 years of age inclusive or older (or the legal age of consent in the jurisdiction), and consent is to be provided by the participant (no pediatric assent procedures). IsVulnerablePopulationSelected is false in the trial record; consent materials (ICFs) are provided for adult participants and in multiple language versions.

Inclusion criteria

  • {"criterion_text":"- Participants must be 18 years of age inclusive or older, at the time of signing the informed consent, or the legal age of consent in the jurisdiction in which the study is taking place\n- Participants with pathologically confirmed advanced solid tumor (key local diagnostic molecular and/or immunophenotyping testing results/ tumor cell phenotype results for confirmed diagnosis should be provided) with no more than 4 lines of prior systemic therapies. Please note: a.\tAdjuvant ± neoadjuvant considered one line of therapy b.\tMaintenance therapy will be considered as part of the preceding line of therapy (i.e., not counted independently) c.\tUnplanned addition or switching to a new drug in a different class is considered a separate line of therapy. If an agent in a regimen is switched to another agent in the same class due to toxicity or intolerance (eg. hypersensitivity reaction) this is considered part of the same line (i.e. not counted independently).\n- Requirements for tumor tissue samples: Archival or fresh tumor tissue is required for retrospective central assessment of B7H4 expression by IHC and other biomarker analysis. The archival tumor tissue should be from the most recent procedure (ideally obtained after the last anti-cancer treatment). If an archival tissue is not available a new biopsy should be performed, and the newly obtained tissue provided.\n- Participants have at least one target lesion as assessed per the RECIST 1.1. A target lesion is defined as a measurable lesion that has not undergone locoregional treatment such as irradiation or that has unequivocal progression following locoregional treatment, with the longest diameter of ≥ 10 mm at baseline.\n- Participants have a life expectancy of at least 12 weeks per investigator assessment based on disease burden and extent of supportive care needed.\n- Is willing to use adequate contraception. Contraceptive use by men or women should be consistent with Protocol Section 10.4\n- Has an ECOG performance status of 0 to 1\n- Participants with normal organ and bone marrow function as defined in Protocol Table 15"}

Exclusion criteria

  • {"criterion_text":"- Has a second malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease\n- Has received treatment with any cytotoxic chemotherapy drugs or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biotherapy and investigational drug) within 30 days or 5 half-lives, whichever is shorter, of a medicinal product prior to the first dose of study drug; or need to continue these drugs during the study\n- Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant\n- Has known sensitivity to study intervention components, GSK5733584 (antibody-drug conjugate, antibody, free cytotoxin GSK5757810A) and combination partner or its excipients or other allergy that, in the opinion of the investigator, contraindicates participation in the study.\n- Has any following cardiological examination abnormality : a. history in prior year of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, New York Heart Association Class III or IV congestive heart failure [1994], or clinically significant arrhythmia not controlled by standard of care therapy. b. QTcF >450 msec or QTcF >480 msec for participants with bundle branch block\n- Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis\n- Use of strong or moderate inhibitors or inducers of CYP3A4, CYP2D6, and inhibitors or inducers of P-gp, and BCRP within 14 days prior to the first dose of study drug; or in need of continuing treatment with these drugs during the study\n- Has serious infections within 4 weeks prior to the first dose, including but not limited to infectious complications, bacteremia, severe pneumonia treated with intravenous antibiotics for ≥2 weeks; Participants who are receiving or have received prophylactic antibiotics (e.g., prophylaxis against urinary infections) are allowed\n- Has chronic inflammatory bowel disease and/or bowel obstruction\n- Has any serious and/or unstable medical condition (such as clinical symptoms of intestinal obstruction) or psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant’s safety, obtainment of informed consent, or compliance to the study procedures.\n- Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary)\n- Clinically significant bleeding symptoms, significant bleeding tendency, or bleeding tumors within 1 month prior to the first dose of study treatment\n- Serious or poorly controlled hypertension, including history of hypertensive crisis, hypertensive encephalopathy; adjustment of antihypertensive medications due to poor blood pressure control within 2 weeks prior to the first dose of study treatment; systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg during screening period\n- Has any active renal condition (e.g., infection, requirement for dialysis, or any other active significant renal condition or dehydrated condition that could affect the participant’s safety). Note: renal obstruction successfully managed by stenting is permitted\n- Is pregnant or breastfeeding\n- Has an ALT value >2.5x ULN and for participants with documented liver metastases/tumor infiltration has an ALT value >5x ULN.\n- Has a total bilirubin value >1.5x ULN. NOTE: Participants with Gilbert’s syndrome can be included with a total bilirubin value <3x ULN, provided direct bilirubin is <1x ULN and participant otherwise meets entry criteria.\n- Has received prior therapy with topoisomerase-1 inhibitors or ADC with topoisomerase-1 inhibitor warhead, or B7H4 targeted therapy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Part A (Dose Exploration) •Percentage of participants with dose limiting toxicities (DLTs) per dose level •Frequency and severity of AEs, imAEs (dostarlimab Modules), AESIs and SAEs per dose level.","definition_or_measurement_approach":"DLTs measured per dose level during the Part A dose-limiting toxicity assessment period; safety measured by frequency and severity of adverse events (AEs), immune-mediated AEs (imAEs, dostarlimab modules), adverse events of special interest (AESIs) and serious adverse events (SAEs) per dose level."}
  • {"endpoint_text":"- Part B Dose Expansion •Clinical activity measured as confirmed ORR assessed by investigator according to RECIST 1.1","definition_or_measurement_approach":"Objective response rate (ORR) confirmed per investigator assessment using RECIST v1.1 criteria."}

Secondary endpoints

  • {"endpoint_text":"- Part A (Dose Exploration) \t •Clinical activity measured as confirmed ORR, DoR, and PFS by dose level assessed by investigator according to RECIST v1.1.","definition_or_measurement_approach":"Confirmed ORR, Duration of Response (DoR), and Progression-Free Survival (PFS) assessed by investigator per RECIST v1.1 by dose level."}
  • {"endpoint_text":"- Part A (Dose Exploration) \t PK parameters (e.g., Cmax, tmax, Ctrough, AUC) for GSK5733584 (conjugated antibody and payload) as data permit.","definition_or_measurement_approach":"Pharmacokinetic parameters including Cmax, Tmax, Ctrough, and AUC for conjugated antibody and payload as measured in plasma samples."}
  • {"endpoint_text":"- Part A (Dose Exploration) •Incidence of ADA, nAb and ADA titers.","definition_or_measurement_approach":"Immunogenicity assessments: incidence of anti-drug antibodies (ADA), neutralizing antibodies (nAb) and ADA titers measured in validated assays."}
  • {"endpoint_text":"- Part A (Dose Exploration) •Changes in vital signs, laboratory measures, ECGs, and Eastern Cooperative Oncology Group Performance Status (ECOG PS) score.","definition_or_measurement_approach":"Safety monitoring via serial vital signs, laboratory tests, ECGs and ECOG PS scoring changes over time."}
  • {"endpoint_text":"- Part B Dose Expansion Clinical activity measured as DoR, PFS assessed by investigator according to RECIST 1.1 and OS","definition_or_measurement_approach":"Duration of Response (DoR), Progression-Free Survival (PFS) by RECIST v1.1 and Overall Survival (OS) as assessed by investigator."}
  • {"endpoint_text":"- Part B Dose Expansion PK parameters (e.g., Cmax, tmax, Ctrough, AUC) for GSK5733584 (conjugated antibody and payload), as data permit","definition_or_measurement_approach":"PK parameters (Cmax, Tmax, Ctrough, AUC) measured for conjugated antibody and payload in plasma samples."}
  • {"endpoint_text":"- Part B Dose Expansion •Incidence of ADA, nAb and ADA titers.","definition_or_measurement_approach":"Immunogenicity: incidence of ADA, nAb and ADA titers assessed by validated assays."}
  • {"endpoint_text":"- Part B Dose Expansion •Frequency and severity of AEs, imAEs (dostarlimab Modules), AESIs and SAEs per dose level •Changes in vital signs, laboratory measures, ECGs, and ECOG PS score.","definition_or_measurement_approach":"Safety endpoints including frequency/severity of AEs, imAEs, AESIs, SAEs by dose level and changes in vitals, labs, ECGs and ECOG PS."}

Recruitment

Digital Remote Recruitment
True, a website recruitment advertisement document (K2_Website recruitment advertisement) is listed among recruitment materials.
Planned Sample Size
175
Recruitment Window Months
34
Consent Approach
Informed consent is to be provided by the participant who is aged ≥18 years or of legal consenting age in their jurisdiction. Multiple language informed consent forms and participant-facing materials are available (documents in English, French, Spanish, Italian, Greek, Polish, Dutch, German, Swedish and other localised versions are listed). Specific ICF modules include general study ICF, genetic research, pregnant participant/partner information; consent handled per local regulations with adult participants providing consent (no pediatric assent is included).

Geography

Total Number Of Sites
48
Total Number Of Participants
217

Poland

Earliest CTIS Part Ii Submission Date
24-04-2025
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
368
Number Of Sites
6
Number Of Participants
22

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oddzial Badan Wczesnych Faz
Contact Person Name
Iwona Lugowska
Contact Person Email
iwona.lugowska@nio.gov.pl
Site Name
Biokinetica S.A.
Contact Person Name
Rafal Stec
Contact Person Email
drrafals@wp.pl
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddzial Onkologii Ginekologicznej
Contact Person Name
Beata Mackowiak-Matejczyk
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddzial Ginekologii Onkologicznej
Contact Person Name
Radoslaw Madry
Contact Person Email
radoslaw.madry@usk.poznan.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
III Klinika Radioterapii i Chemioterapii
Contact Person Name
Rafal Tarnawski
Contact Person Email
rafaltarnawski@gmail.com
Site Name
Lux Med Onkologia Sp. z o.o.
Department Name
Szpital Szamocka, Oddział onkologii klinicznej/chemioterapii
Contact Person Name
Maciej Studzinski
Contact Person Email
maciej.studzinski@luxmed.pl

Spain

Earliest CTIS Part Ii Submission Date
08-04-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
381
Number Of Sites
10
Number Of Participants
52

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncología Médica
Contact Person Name
Luis Manso Sánchez
Contact Person Email
lmanso@salud.madrid.org
Site Name
Hospital Universitario Miguel Servet
Department Name
Oncología Médica
Contact Person Name
Eugenia Ortega Izquierdo
Contact Person Email
meortegai@salud.aragon.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología Médica
Contact Person Name
Roberta Mazzeo
Contact Person Email
robertamazzeo@vhio.net
Site Name
Hospital Hm Nou Delfos
Department Name
Oncologia, Ensayos Clinicos Fases I START-Barcelona
Contact Person Name
Tatiana Hernández Guerrero
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncología Médica
Contact Person Name
María Quindós Varela
Contact Person Email
Maria.Quindos.Varela@sergas.es
Site Name
Hospital Clinic De Barcelona
Department Name
Oncología Médica
Contact Person Name
Lydia Gaba García
Contact Person Email
lgaba@clinic.cat
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
IBIMA Phase 1 Unit. Medical Oncology
Contact Person Name
Javier García Corbacho
Contact Person Email
fasestempranas@ibima.eu
Site Name
MD Anderson Cancer Center
Department Name
Oncología Médica
Contact Person Name
Raúl Márquez Vázquez
Contact Person Email
raulmarquez@mdanderson.es
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncología Médica
Contact Person Name
Ignacio Romero Noguera
Contact Person Email
iromero@fivo.org
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncologfa, Ensayos Clfnicos Fases I START Madrid-CIOCC
Contact Person Name
Ramón Yarza Barrio
Contact Person Email
Ramon.Yarza@startmadrid.com

Belgium

Earliest CTIS Part Ii Submission Date
25-04-2025
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
368
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Medical Oncology
Contact Person Name
Sylvie Rottey
Contact Person Email
drug@uzgent.be
Site Name
UZ Leuven
Department Name
Gynaecological Oncology
Contact Person Name
Toon Van Gorp
Contact Person Email
gynoncologie@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Contact Person Name
Jean-François Baurain
Site Name
Centre hospitalier universitaire de Liege
Department Name
Medical Oncology
Contact Person Name
Christine Gennigens

Netherlands

Earliest CTIS Part Ii Submission Date
25-04-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
364
Number Of Sites
3
Number Of Participants
22

Sites

Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Medical Oncology
Contact Person Name
Tim Schutte
Contact Person Email
fase1secretariaat@nki.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Internal Oncology
Contact Person Name
Sander Bins
Contact Person Email
s.bins@erasmusumc.nl
Site Name
Amsterdam UMC Stichting
Department Name
Medical Oncology
Contact Person Name
Willemien Menke - van der Houven van Oordt
Contact Person Email
phase1@amsterdamumc.nl

Germany

Earliest CTIS Part Ii Submission Date
07-04-2025
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
385
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Universitaet Leipzig
Contact Person Name
Gertraud Stocker
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Contact Person Name
Alexander Desuki
Site Name
Klinikum der Universitaet Muenchen AöR
Contact Person Name
Lena Weiss
Contact Person Email
Lena.Weiss@med.uni-muenchen.de
Site Name
University Of Cologne
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Christian Maurer
Contact Person Email
christian.maurer@uk-koeln.de

Italy

Earliest CTIS Part Ii Submission Date
28-03-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
392
Number Of Sites
6
Number Of Participants
27

Sites

Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione Sviluppo di Nuovi Farmaci per Terapie Innovative
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Programma Studi Fase I SC Sperimentazioni Cliniche
Contact Person Name
Adriano Gravina
Contact Person Email
a.gravina@istitutotumori.na.it
Site Name
Istituto Oncologico Veneto
Department Name
Centro Sperimentazioni di Fase I, UOC Oncologia 2
Contact Person Name
Valentina Guarneri
Contact Person Email
valentina.guarneri@unipd.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Unità di Fase 1 Unità di Farmacologia Clinica
Contact Person Name
Vanda Salutari
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Unità di Fase 1 Unità di Farmacologia Clinica
Contact Person Name
Gennaro Daniele
Site Name
Humanitas Mirasole S.p.A.
Department Name
Unità di Fase I, UO Ginecologia Oncologia Medica
Contact Person Name
Domenica Lorusso
Contact Person Email
domenica.lorusso@hunimed.eu

Sweden

Earliest CTIS Part Ii Submission Date
03-04-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
386
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Karolinska University Hospital
Department Name
Centrum för Kliniska Cancerstudier Tema Cancer
Contact Person Name
Lisa Liu Burström

France

Earliest CTIS Part Ii Submission Date
03-04-2025
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
385
Number Of Sites
5
Number Of Participants
37

Sites

Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Val D'Aurelle - Department Medical Oncology
Contact Person Name
Diego TOSI
Contact Person Email
diego.tosi@icm.unicancer.fr
Site Name
Hospices Civils De Lyon
Department Name
Department Medical oncology
Contact Person Name
Benoit YOU
Contact Person Email
benoit.you@chu-lyon.fr
Site Name
Institut Paoli Calmettes
Department Name
Département d'Oncologie Médicale
Contact Person Name
Renaud SABATIER
Contact Person Email
sabatierr@ipc.unicancer.fr
Site Name
Centre Leon Berard
Department Name
Department Medical Oncology
Contact Person Name
Isabelle RAY-COQUARD
Site Name
Institut Gustave Roussy
Department Name
Department of Early Drug Development and Genitourinary Oncology Group
Contact Person Name
Yohann LORIOT
Contact Person Email
yohann.loriot@gustaveroussy.fr

Denmark

Earliest CTIS Part Ii Submission Date
17-04-2025
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
371
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Region Hovedstaden
Department Name
Department of Oncology Herlev University Hospital
Contact Person Name
Rikke Eefsen
Site Name
Rigshospitalet
Department Name
Department of Oncology, Phase 1 Unit
Contact Person Name
Kristoffer Rohrberg

Finland

Earliest CTIS Part Ii Submission Date
08-04-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
381
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Tampere University Hospital
Department Name
FONK (oncological clinical trial unit)
Contact Person Name
Annika Auranen
Contact Person Email
etunimi.sukunimi@pirha.fi
Site Name
HUS-Yhtymae
Department Name
HUS Comprehensive Cancer center
Contact Person Name
Katriina Jalkanen
Contact Person Email
etunimi.sukunimi@hus.fi

Greece

Earliest CTIS Part Ii Submission Date
28-01-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
451
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
University General Hospital Attikon
Department Name
2nd Propaedeutic Dept of Internal Medicine, Oncology Unit, Research Unit
Contact Person Name
Amanda Psyrri
Contact Person Email
psyrri237@yahoo.com
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
St. Luke's Hospital S.A.
Department Name
Department of Medical Oncology
Contact Person Name
Eleni Fountzila
Contact Person Email
elenafou@gmail.com
Site Name
Alexandra Hospital
Department Name
Oncology Unit, Department of Clinical Therapeutics
Contact Person Name
Michalis Liontos
Contact Person Email
mliontos@gmail.com

Norway

Earliest CTIS Part Ii Submission Date
10-04-2025
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
383
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Oslo University Hospital HF
Department Name
Department of Oncology
Contact Person Name
Kristina Lindemann
Contact Person Email
post.akb@ous-hf.no

Sponsor

Primary sponsor

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

Contract research organisations

Name
PPD International Holdings LLC
Responsibilities
sponsorDuties codes: [4]
Name
Sermes CRO
Responsibilities
Patient fee reimbursement (sponsorDuties code: 15 / described role)
Name
Charles River Laboratories Inc.
Responsibilities
sponsorDuties codes: [4]

Third parties

  • {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Glaxosmithkline LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Primera Analytical Solutions Corp.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"France","full_name":"Fm Richard Et Associes","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"Patient fee reimbursement","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Clinops Tomasz Lusawa","duties_or_roles":"Renting equipment/medical devices to GSK for clinical sites","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Glaxosmithkline LLC (additional address)","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"medicine product destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"IL-CSM Clinical Supplies Management GmbH","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"ZALARIS Deutschland GmbH","duties_or_roles":"Patient Reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Let Me Pay Sp. z o.o.","duties_or_roles":"Patient fee reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"sponsorDuties codes: [7] (digital/remote platform services)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Charles River Laboratories Edinburgh Limited","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
GSK5733584
Active Substance
GSK5733584
Modality
ADC
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Investigational (prodAuthStatus: 1)
Investigational Product Name
Avastin (bevacizumab)
Active Substance
BEVACIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (EU marketing authorisation)
Investigational Product Name
Carboplatino Hikma (carboplatin)
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation)
Investigational Product Name
Cisplatino Accord Healthcare Italia (cisplatin)
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation)
Investigational Product Name
JEMPERLI (dostarlimab)
Active Substance
DOSTARLIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation EU/1/21/1538/001)
Combination Treatment
Yes

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