Clinical trial • Phase II • Oncology
RINATABART SESUTECAN for Non-small cell lung cancer | Locally advanced or metastatic non-small cell lung cancer
Phase II trial of RINATABART SESUTECAN for Non-small cell lung cancer | Locally advanced or metastatic non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer | Locally advanced or metastatic non-small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- ADC | Peptide/protein/enzyme
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 01-12-2025
- First CTIS Authorization Date
- 14-04-2026
Trial design
open-label, none/not specified-controlled Phase II trial in Belgium, France, Germany and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Biomarker Stratified
- True, actionable genetic alterations (AGAs): strata = AGA vs no AGA
- Target Sample Size
- 93
- Trial Duration For Participant
- 1095
Eligibility
Recruits 93 paediatric patients.
- Vulnerable Population
- Vulnerable populations selected. Subject information and informed consent form (SIS-ICF) documents are provided for pregnant participants and pregnant partners and there is a specific 'Child data collection' SIS-ICF document (French). Multiple country-specific SIS-ICF and consent documents are included (e.g., Dutch, French, German, Hungarian, Italian, Spanish, Polish). The presence of child data collection and pregnancy-specific ICFs indicates inclusion of children and pregnant participants as vulnerable populations; specific parental consent/assent procedures are referenced by the presence of child data collection and SIS-ICF documents but detailed assent/consent process text is not provided in the extracted content.
Inclusion criteria
- {"criterion_text":"- Participant has histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or radiotherapy.\n- Participant must have radiological disease progression while on or after receiving the most recent regimen.\n- Participants either may have actionable genetic alterations (AGAs) or no AGAs.\n- Participant has measurable disease according to RECIST v1.1.\n- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 within 7 days of Cycle 1 Day 1."}
Exclusion criteria
- {"criterion_text":"- Participant has NSCLC with histology other than adenocarcinoma\n- Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5- year OS ≥ 90%), including, but not limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥ 3 years.\n- Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). Participants with history of spinal cord compression (from disease). Participants with previous CNS-directed therapy (eg, radiotherapy and/or surgery) for brain metastases may participate provided lesion(s) are radiologically stable (ie, without evidence of progression) for at least 28 days by repeat imaging."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator [Time Frame: Approximately 3 years]","definition_or_measurement_approach":"ORR measured per RECIST v1.1 assessed by investigator; time frame approximately 3 years."}
Secondary endpoints
- {"endpoint_text":"- 1.Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years]\n- 2.Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years]\n- 3.Progression-free Survival (PFS) [Time Frame: Approximately 4 years]\n- 4.Overall Survival (OS) [Time Frame: Approximately 4 years]\n- 5.Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes [Time Frame: Approximately 12 months]\n- 6.Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes[Time Frame: Approximately 12 months]\n- 7.Number of Participants with Antidrug Antibodies (ADAs) [Time Frame: Approximately 12 months]\n- 8.Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Approximately 4 years]","definition_or_measurement_approach":"DOR, DCR measured per RECIST v1.1 as assessed by investigator (time frame ~4 years). PFS and OS measured as standard survival endpoints (time frame ~4 years). PK endpoints (Cmax, Tmax) measured for Rina-S related analytes (time frame ~12 months). Immunogenicity endpoint: number with ADAs (time frame ~12 months). Safety: number with TEAEs (time frame ~4 years)."}
Recruitment
- Digital Remote Recruitment
- True, Mural Health digital recruitment materials (Mural participant form, link verbiage, mobile web and app screenshots, privacy policy, terms & conditions, notifications, travel/reference guides) are included; these indicate use of an app/web platform for participant engagement and remote data collection.
- Planned Sample Size
- 93
- Recruitment Window Months
- 9
- Consent Approach
- Informed consent is handled via country-specific SIS-ICF (subject information and informed consent form) documents. Main SIS-ICF forms and specific SIS-ICF documents for pregnant participants, pregnant partners, and child data collection are provided. Multiple language versions are present across countries (documents listed in Dutch, French, German, Hungarian, Italian, Spanish, Polish, and English). Consent is obtained using these SIS-ICF documents; child-specific data collection forms and pregnancy-specific ICFs indicate tailored consent materials for vulnerable subgroups (parental consent/child data collection forms are included though detailed assent procedures are not explicit in the extracted content).
Methods
- Physician-to-Physician letters (K2 documents listed for multiple countries) — channel: direct communication between treating physicians to notify potential referring physicians about the trial.
- General Practitioner letters (K2 documents present e.g., France) — channel: letters to GPs to assist identification/referral of potential participants.
- Country-specific recruitment procedures (K1 Recruitment Procedure documents listed for Belgium, France, Germany, Italy, Spain, Netherlands, Poland, Hungary) — outlines local recruitment workflows per country (documented as K1 for each country).
- Digital/remote recruitment via Mural Health platform (Hungary-specific materials listed: Mural Health Participant Form, Mural Link Verbiage, Mural mobile web and app screenshots, Mural privacy/terms, patient app reference guides) — channel: digital app/web targeted to participants to support remote engagement and study procedures.
Geography
- Total Number Of Sites
- 49
- Total Number Of Participants
- 107
Belgium
- Earliest CTIS Part Ii Submission Date
- 09-01-2026
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 97
- Number Of Sites
- 6
- Number Of Participants
- 12
Sites
- Site Name
- Institut Jules Bordet
- Department Name
- Lung Oncology
- Principal Investigator Name
- Mariana Da Rocha Almeida Brandao
- Principal Investigator Email
- mariana.brandao@hubruxelles.be
- Contact Person Name
- Mariana Da Rocha Almeida Brandao
- Contact Person Email
- mariana.brandao@hubruxelles.be
- Site Name
- UZ Leuven
- Department Name
- Respiratory Oncology
- Principal Investigator Name
- Christophe Dooms
- Principal Investigator Email
- christophe.dooms@uzleuven.be
- Contact Person Name
- Christophe Dooms
- Contact Person Email
- christophe.dooms@uzleuven.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Thoracic Oncology
- Principal Investigator Name
- Reinier Wener
- Principal Investigator Email
- reinier.wener@uza.be
- Contact Person Name
- Reinier Wener
- Contact Person Email
- reinier.wener@uza.be
- Site Name
- CHU Helora
- Department Name
- Medical Oncology
- Principal Investigator Name
- Gaetan Catala
- Principal Investigator Email
- gaetan.catala@helora.be
- Contact Person Name
- Gaetan Catala
- Contact Person Email
- gaetan.catala@helora.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Pneumology
- Principal Investigator Name
- Ingel Demedts
- Principal Investigator Email
- ingel.demedts@azdelta.be
- Contact Person Name
- Ingel Demedts
- Contact Person Email
- ingel.demedts@azdelta.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- Pneumology
- Principal Investigator Name
- Kristof Cuppens
- Principal Investigator Email
- kristof.cuppens@jessazh.be
- Contact Person Name
- Kristof Cuppens
- Contact Person Email
- kristof.cuppens@jessazh.be
France
- Earliest CTIS Part Ii Submission Date
- 01-04-2026
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 15
- Number Of Sites
- 7
- Number Of Participants
- 16
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Pneumology
- Principal Investigator Name
- Sébastien COURAUD
- Principal Investigator Email
- sebastien.couraud@chu-lyon.fr
- Contact Person Name
- Sébastien COURAUD
- Contact Person Email
- sebastien.couraud@chu-lyon.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Multidisciplinary Oncology and Therapeutic Innovation
- Principal Investigator Name
- Pascale TOMASINI
- Principal Investigator Email
- Pascale.tomasini@ap-hm.fr
- Contact Person Name
- Pascale TOMASINI
- Contact Person Email
- Pascale.tomasini@ap-hm.fr
- Site Name
- Institut Curie
- Department Name
- Pneumology
- Principal Investigator Name
- Nicolas GIRARD
- Principal Investigator Email
- Nicolas.girard2@curie.fr
- Contact Person Name
- Nicolas GIRARD
- Contact Person Email
- Nicolas.girard2@curie.fr
- Site Name
- Fondation Hopital Saint Joseph
- Department Name
- Oncology
- Principal Investigator Name
- Carole HELISSEY
- Principal Investigator Email
- chelissey@ghpsj.fr
- Contact Person Name
- Carole HELISSEY
- Contact Person Email
- chelissey@ghpsj.fr
- Site Name
- Hospices Civils De Lyon (Pierre Benite site)
- Department Name
- Pneumology
- Principal Investigator Name
- Sébastien COURAUD
- Principal Investigator Email
- sebastien.couraud@chu-lyon.fr
- Contact Person Name
- Sébastien COURAUD
- Contact Person Email
- sebastien.couraud@chu-lyon.fr
- Site Name
- Hospices Civils De Lyon (Bron site)
- Department Name
- Pneumology
- Principal Investigator Name
- Sébastien COURAUD
- Principal Investigator Email
- sebastien.couraud@chu-lyon.fr
- Contact Person Name
- Sébastien COURAUD
- Contact Person Email
- sebastien.couraud@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pneumology
- Principal Investigator Name
- Marie WISLEZ
- Principal Investigator Email
- marie.wislez@aphp.fr
- Contact Person Name
- Marie WISLEZ
- Contact Person Email
- marie.wislez@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 25-03-2026
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- Department of Thoracic Oncology
- Principal Investigator Name
- Farastuk Bozorgmehr
- Principal Investigator Email
- farastuk.bozorgmehr@med.uni-heidelberg.de
- Contact Person Name
- Farastuk Bozorgmehr
- Contact Person Email
- farastuk.bozorgmehr@med.uni-heidelberg.de
- Site Name
- Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
- Department Name
- Clinic for Pneumology
- Principal Investigator Name
- Christian Grohe
- Principal Investigator Email
- christian.grohe@pgdiakonie.de
- Contact Person Name
- Christian Grohe
- Contact Person Email
- christian.grohe@pgdiakonie.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Department of medical oncology
- Principal Investigator Name
- Halime Kalkavan
- Principal Investigator Email
- Halime.kalkavan@kuk-essen.de
- Contact Person Name
- Halime Kalkavan
- Contact Person Email
- Halime.kalkavan@kuk-essen.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 23-02-2026
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 56
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Bacs-Kiskun Varmegyei Oktatokorhaz
- Department Name
- Onkoradiológiai Központ
- Principal Investigator Name
- Judit KOCSIS
- Principal Investigator Email
- kocsisjucidr@gmail.com
- Contact Person Name
- Judit KOCSIS
- Contact Person Email
- kocsisjucidr@gmail.com
- Site Name
- Komarom-Esztergom Varmegyei Szent Borbala Korhaz
- Department Name
- Tüdőgyógyászati Onkológiai Gondozó
- Principal Investigator Name
- Nóra BITTNER
- Principal Investigator Email
- nora_bittner@yahoo.ca
- Contact Person Name
- Nóra BITTNER
- Contact Person Email
- nora_bittner@yahoo.ca
- Site Name
- Clinic Of Pulmonology Semmelweis University
- Department Name
- -
- Principal Investigator Name
- Veronika MÜLLER
- Principal Investigator Email
- muller.veronika@med.semmelweis-univ.hu
- Contact Person Name
- Veronika MÜLLER
- Contact Person Email
- muller.veronika@med.semmelweis-univ.hu
Italy
- Earliest CTIS Part Ii Submission Date
- 30-03-2026
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 16
- Number Of Sites
- 7
- Number Of Participants
- 12
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Oncologia Medica
- Principal Investigator Name
- Emilio Bria
- Principal Investigator Email
- Emilio.bria@policlinicogemelli.it
- Contact Person Name
- Emilio Bria
- Contact Person Email
- Emilio.bria@policlinicogemelli.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- U.O. Oncologia, Dipartimento OncoEmatologico
- Principal Investigator Name
- Manolo D’Arcangelo
- Principal Investigator Email
- manolo.darcangelo@auslromagna.it
- Contact Person Name
- Manolo D’Arcangelo
- Contact Person Email
- manolo.darcangelo@auslromagna.it
- Site Name
- Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Vanesa Gregorc
- Principal Investigator Email
- vanesa.gregorc@ircc.it
- Contact Person Name
- Vanesa Gregorc
- Contact Person Email
- vanesa.gregorc@ircc.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Department of PrecisionMedicine
- Principal Investigator Name
- Floriana Morgillo
- Principal Investigator Email
- Floriana.morgillo@unicampania.it
- Contact Person Name
- Floriana Morgillo
- Contact Person Email
- Floriana.morgillo@unicampania.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- SCSU Medical Oncology
- Principal Investigator Name
- Silvia Novello
- Principal Investigator Email
- Silvia.novello@unito.it
- Contact Person Name
- Silvia Novello
- Contact Person Email
- Silvia.novello@unito.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- S.S.D. Oncologia Toracica
- Principal Investigator Name
- Angelo Delmonte
- Principal Investigator Email
- angelo.delmonte@irst.emr.it
- Contact Person Name
- Angelo Delmonte
- Contact Person Email
- angelo.delmonte@irst.emr.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS (additional listed site address)
- Department Name
- UOC Oncologia Medica
- Principal Investigator Name
- Emilio Bria
- Principal Investigator Email
- Emilio.bria@policlinicogemelli.it
- Contact Person Name
- Emilio Bria
- Contact Person Email
- Emilio.bria@policlinicogemelli.it
Spain
- Earliest CTIS Part Ii Submission Date
- 12-03-2026
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 39
- Number Of Sites
- 16
- Number Of Participants
- 30
Sites
- Site Name
- MD Anderson Cancer Center
- Department Name
- Oncology
- Principal Investigator Name
- Fernando Fábio Franco Pérez
- Principal Investigator Email
- ffranco@fundacionmdanderson.es
- Contact Person Name
- Fernando Fábio Franco Pérez
- Contact Person Email
- ffranco@fundacionmdanderson.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Manuel Domine Gomez
- Principal Investigator Email
- mdomine@fjd.es
- Contact Person Name
- Manuel Domine Gomez
- Contact Person Email
- mdomine@fjd.es
- Site Name
- Instituto Oncologico Dr. Rosell S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Roxana Reyes Cabanillas
- Principal Investigator Email
- rreyes@oncorosell.com
- Contact Person Name
- Roxana Reyes Cabanillas
- Contact Person Email
- rreyes@oncorosell.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz (additional listed site)
- Department Name
- Oncology
- Principal Investigator Name
- Manuel Domine Gomez
- Principal Investigator Email
- mdomine@fjd.es
- Contact Person Name
- Manuel Domine Gomez
- Contact Person Email
- mdomine@fjd.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Maria Saigi Morgui
- Principal Investigator Email
- uicico_badalona@iconcologia.net
- Contact Person Name
- Maria Saigi Morgui
- Contact Person Email
- uicico_badalona@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Javier Torres Jimenez
- Principal Investigator Email
- javier.torres@salud.madrid.org
- Contact Person Name
- Javier Torres Jimenez
- Contact Person Email
- javier.torres@salud.madrid.org
- Site Name
- Hospital Quironsalud Malaga
- Department Name
- Oncology
- Principal Investigator Name
- Manuel Cobo Dols
- Principal Investigator Email
- manuelcobodols@yahoo.es
- Contact Person Name
- Manuel Cobo Dols
- Contact Person Email
- manuelcobodols@yahoo.es
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Oncology
- Principal Investigator Name
- Maria del Rosario Garcia Campelo
- Principal Investigator Email
- ma.rosario.garcia.campelo@sergas.es
- Contact Person Name
- Maria del Rosario Garcia Campelo
- Contact Person Email
- ma.rosario.garcia.campelo@sergas.es
- Site Name
- Clinica Universidad De Navarra (Madrid)
- Department Name
- Oncology
- Principal Investigator Name
- Miguel Fernandez de Sanmamed
- Principal Investigator Email
- msanmamed@unav.es
- Contact Person Name
- Miguel Fernandez de Sanmamed
- Contact Person Email
- msanmamed@unav.es
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Sergio Sandiego Contreras
- Principal Investigator Email
- ssandiego@fivo.org
- Contact Person Name
- Sergio Sandiego Contreras
- Contact Person Email
- ssandiego@fivo.org
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology
- Principal Investigator Name
- Maria Insa Molla
- Principal Investigator Email
- ameliainsamolla@gmail.com
- Contact Person Name
- Maria Insa Molla
- Contact Person Email
- ameliainsamolla@gmail.com
- Site Name
- Hospital Del Mar
- Department Name
- Oncology
- Principal Investigator Name
- Edurne Arriola Aperribay
- Principal Investigator Email
- earriola@parcdesalutmar.cat
- Contact Person Name
- Edurne Arriola Aperribay
- Contact Person Email
- earriola@parcdesalutmar.cat
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Oncology
- Principal Investigator Name
- Miguel Fernandez de Sanmamed
- Principal Investigator Email
- msanmamed@unav.es
- Contact Person Name
- Miguel Fernandez de Sanmamed
- Contact Person Email
- msanmamed@unav.es
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Oncology
- Principal Investigator Name
- Delvys Rodriguez Abreu
- Principal Investigator Email
- drodabr@gobiernodecanarias.org
- Contact Person Name
- Delvys Rodriguez Abreu
- Contact Person Email
- drodabr@gobiernodecanarias.org
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Principal Investigator Name
- Rosa Maria Alvarez Alvarez
- Principal Investigator Email
- ralvareza@salud.madrid.org
- Contact Person Name
- Rosa Maria Alvarez Alvarez
- Contact Person Email
- ralvareza@salud.madrid.org
- Site Name
- Institut Catala D'oncologia (additional listed site)
- Department Name
- Oncology
- Principal Investigator Name
- Maria Saigi Morgui
- Principal Investigator Email
- uicico_badalona@iconcologia.net
- Contact Person Name
- Maria Saigi Morgui
- Contact Person Email
- uicico_badalona@iconcologia.net
Netherlands
- Earliest CTIS Part Ii Submission Date
- 01-04-2026
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 13
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Department of Pulmonary Diseases
- Principal Investigator Name
- Egbert Frederik Smit
- Principal Investigator Email
- e.f.smit@lumc.nl
- Contact Person Name
- Egbert Frederik Smit
- Contact Person Email
- e.f.smit@lumc.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Department of Pulmonary Diseases
- Principal Investigator Name
- Wilhelmina Sabina Marilyn Emilie Theelen
- Principal Investigator Email
- w.theelen@nki.nl
- Contact Person Name
- Wilhelmina Sabina Marilyn Emilie Theelen
- Contact Person Email
- w.theelen@nki.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 11-03-2026
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 40
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Med Polonia Sp. z o.o.
- Department Name
- Przychodnia MED-Polonia
- Principal Investigator Name
- Rodryg Ramlau
- Principal Investigator Email
- badania.kliniczne@medpolonia.com.pl
- Contact Person Name
- Rodryg Ramlau
- Contact Person Email
- badania.kliniczne@medpolonia.com.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Płuca i Klatki Piersiowej
- Principal Investigator Name
- Dariusz Kowalski
- Principal Investigator Email
- Dariusz.kowalski@nio.gov.pl
- Contact Person Name
- Dariusz Kowalski
- Contact Person Email
- Dariusz.kowalski@nio.gov.pl
- Site Name
- Instytut Msf Sp. z o.o.
- Department Name
- Instytut MSF
- Principal Investigator Name
- Ewa Kalinka
- Principal Investigator Email
- Imsf.clinicaltrials@gmail.com
- Contact Person Name
- Ewa Kalinka
- Contact Person Email
- Imsf.clinicaltrials@gmail.com
- Site Name
- PRZYCHODNIA LEKARSKA ”KOMED” ROMAN KARASZEWSKI
- Department Name
- PRZYCHODNIA LEKARSKA ”KOMED”
- Principal Investigator Name
- Bogusława Karaszewska
- Principal Investigator Email
- komed.badania@gmail.com
- Contact Person Name
- Bogusława Karaszewska
- Contact Person Email
- komed.badania@gmail.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Ośrodek Badań Klinicznych Wczesnych Faz
- Principal Investigator Name
- Dariusz Dziadziuszko
- Principal Investigator Email
- obkwf@uck.gda.pl
- Contact Person Name
- Dariusz Dziadziuszko
- Contact Person Email
- obkwf@uck.gda.pl
Sponsor
Primary sponsor
- Full Name
- Genmab A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- CRO
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Fortrea Development Limited","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Mural Health Technologies Inc.","duties_or_roles":"Patient reimbursement support","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Rinatabart Sesutecan
- Active Substance
- RINATABART SESUTECAN
- Modality
- ADC
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
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