Clinical trial • Phase III • Oncology

RINATABART SESUTECAN for Platinum-resistant ovarian cancer

Phase III trial of RINATABART SESUTECAN for Platinum-resistant ovarian cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Platinum-resistant ovarian cancer
Trial Stage
Phase III
Drug Modality
ADC|Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
28-01-2025
First CTIS Authorization Date
20-05-2025

Trial design

Randomised, open-label, investigator's choice (ic) - comparator options include paclitaxel (max daily dose reported 80 mg/m2, iv infusion), doxorubicin (max daily dose reported 40 mg/m2, iv infusion), gemcitabine (max daily dose reported 1000 mg/m2, iv infusion), topotecan (max daily dose reported 4 mg/m2, iv infusion).-controlled Phase III trial in Belgium, Czechia, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator's choice (IC) - comparator options include paclitaxel (max daily dose reported 80 mg/m2, IV infusion), doxorubicin (max daily dose reported 40 mg/m2, IV infusion), gemcitabine (max daily dose reported 1000 mg/m2, IV infusion), topotecan (max daily dose reported 4 mg/m2, IV infusion).
Target Sample Size
361

Eligibility

Recruits 361 No vulnerable population selected (isVulnerablePopulationSelected: false). Trial enrols adult female patients only; informed consent is to be provided by the participant. No assent/guardian consent provisions for minors are described in the available trial documentation..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Trial enrols adult female patients only; informed consent is to be provided by the participant. No assent/guardian consent provisions for minors are described in the available trial documentation.

Inclusion criteria

  • {"criterion_text":"- 1. Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n- 2. Participants may be enrolled regardless of FRα expression level.\n- 3. Participants must have received 1 to 4 prior lines of therapy. Patients must have progressed radiographically on or after their most recent line of therapy.\n- 4. Participants must have received prior treatment with the following therapies: • Platinum chemotherapy • Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the patient is not eligible for treatment with bevacizumab (or biosimilar) due to precautions/intolerance • Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the participant is not eligible for treatment with PARP inhibitor • Mirvetuximab soravtansine, if: • Mirvetuximab soravtansine is available in the enrollment region, and • The participant is eligible based on positive FRα expression per Food and Drug Administration (FDA)-approved (or local equivalent) test, and • The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision.\n- 5. Participants must have platinum-resistant disease: • Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between > 91 days and ≤ 183 days after the date of the last dose of platinum. • Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum."}

Exclusion criteria

  • {"criterion_text":"- 1. Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.\n- 2. Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen.\n- 3. History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer.\n- 4. Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.\n- 5. Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.\n- 6. Ascites requiring frequent paracentesis (more often than approximately every 4 weeks) for symptomatic management. Enrollment of participants with an indwelling peritoneal catheter must be discussed with the medical monitor to determine eligibility."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-Free Survival (PFS) PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.","definition_or_measurement_approach":"PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause, whichever occurs first, based on RECIST v1.1 as assessed by the investigator."}

Secondary endpoints

  • {"endpoint_text":"- 1. Overall Survival (OS) OS is defined as the time from date of randomization to date of death due to any cause.","definition_or_measurement_approach":"OS is defined as the time from date of randomization to date of death due to any cause."}
  • {"endpoint_text":"- 2. Objective Response Rate (ORR) ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator.","definition_or_measurement_approach":"ORR = percentage of participants with BOR of CR or PR per RECIST v1.1 as assessed by investigator."}
  • {"endpoint_text":"- 4. Duration of Response (DOR) DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator and BICR.","definition_or_measurement_approach":"DOR = time from onset date of response to first documented progression or death per RECIST v1.1, assessed by investigator and BICR."}
  • {"endpoint_text":"- 5. Percentage of Participants Who Achieved Cancer Antigen-125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline.","definition_or_measurement_approach":"CA-125 response defined as ≥50% reduction from baseline per GCIG criteria."}
  • {"endpoint_text":"- 6. Time to Second Disease Progression or Death From any Cause (PFS2) PFS2 is defined as the time from randomization to the date of the second PD (i.e., the first PD reported in subsequent anti-cancer therapies, or long-term follow up) or death.","definition_or_measurement_approach":"PFS2 = time from randomization to date of second PD or death."}
  • {"endpoint_text":"- 9. Overall Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Overall change from baseline in GHS/Qol score (items 29 and 30) will be calculated using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC-QLQ-C30) questionnaire. The score ranges from 0 to 100. A high scale score represents a higher response level.","definition_or_measurement_approach":"Overall change from baseline in GHS/QoL score (items 29 and 30) measured using EORTC-QLQ-C30; scores 0–100."}
  • {"endpoint_text":"- 10. Time to Deterioration (TTD) in the GHS/Qol Score TTD in the GHS/Qol score is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) in GHS/QoL score. A longer TTD indicates a better outcome.","definition_or_measurement_approach":"TTD = time from baseline to first ≥10-point decrease in GHS/QoL score."}
  • {"endpoint_text":"- 7. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Laboratory Abnormalities","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 8. Change From Baseline in Electrocardiogram (ECG) Findings to Assess Changes in QTc Associated with Rina-S by Holter Monitor","definition_or_measurement_approach":"Change from baseline in ECG parameters (QTc) assessed by Holter monitor."}
  • {"endpoint_text":"- 3. Progression Free Survival (PFS) and ORR, per RECIST v1.1, as determined by blinded independent central review (BICR)","definition_or_measurement_approach":"PFS and ORR assessed per RECIST v1.1 by blinded independent central review (BICR)."}

Recruitment

Planned Sample Size
361
Recruitment Window Months
47
Consent Approach
Informed consent is provided by the participant. Subject information and informed consent forms are provided per country in local languages (country-specific ICFs are included in the application documents; examples include Dutch, French, Czech, Italian, Greek, Norwegian, Danish, German, Polish, Spanish). No assent or guardian consent provisions for minors are described in the available documentation.

Geography

Total Number Of Sites
86
Total Number Of Participants
171

Belgium

Earliest CTIS Part Ii Submission Date
15-04-2025
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
325
Number Of Sites
7
Number Of Participants
13

Sites

Site Name
CHU Saint Pierre
Department Name
Oncology
Contact Person Name
Corina Martinez-Mena
Site Name
Grand Hopital De Charleroi
Department Name
Clinique du sein - Oncologie gynécologique
Contact Person Name
Alix Devaux
Contact Person Email
alix.devaux@ghdc.com
Site Name
CHC MontLegia
Department Name
Hemato-Oncology
Contact Person Name
Maryam Bourhaba
Contact Person Email
maryam.bourhaba@chc.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Medical Oncology
Contact Person Name
Marlies De Bock
Contact Person Email
marlies.debock@azdelta.be
Site Name
Onze-Lieve-Vrouwziekenhuis
Department Name
Oncology
Contact Person Name
Greet Huygh
Contact Person Email
greet.huygh@olvz-aalst.be
Site Name
UZ Leuven
Department Name
Gyneacology-obstetrics
Contact Person Name
Toon Van Gorp
Contact Person Email
toon.vangorp@uzleuven.be
Site Name
AZ Turnhout
Department Name
Centrum voor Oncologie
Contact Person Name
Cleo De Backer
Contact Person Email
Cleo.debacker@azturnhout.be

Czechia

Earliest CTIS Part Ii Submission Date
04-04-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
339
Number Of Sites
8
Number Of Participants
14

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Department of Oncology 2nd Medical Faculty
Contact Person Name
Anna Nohejlová Medková
Contact Person Email
anna.nohejlova@fnmotol.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Michael J. Halaška
Contact Person Email
michael.halaska@fnkv.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Munachiso Ndukwe
Contact Person Email
munachiso.ndukwe@fnhk.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Department of clinical oncology
Contact Person Name
Mária Zvaríková
Contact Person Email
zvarikova@mou.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Complex Oncology Center, Department of Oncology and Radiotherapy
Contact Person Name
Vlastimil Tlustý
Contact Person Email
vojtech.tlusty@nnj.agel.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
David Cibula
Contact Person Email
david.cibula@vfn.cz
Site Name
Fakultni Nemocnice Bulovka
Department Name
Gynecology and obstetrics clinic
Contact Person Name
Michal Zikán
Contact Person Email
michal.zikan@bulovka.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady (duplicate listing if present)
Department Name
Department of Obstetrics and Gynecology

Italy

Earliest CTIS Part Ii Submission Date
27-03-2025
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
344
Number Of Sites
12
Number Of Participants
25

Sites

Site Name
Ente Ospedaliero Ospedali Galliera Di Genova
Department Name
Struttura Complessa Oncologia Medica
Contact Person Name
Monica Boitano
Contact Person Email
monica.boitano@galliera.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncologia Medica Divisione 1
Contact Person Name
Antonella Savarese
Contact Person Email
antonella.savarese@ifo.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Unità di Oncologia Ginecologica
Contact Person Name
Francesco Raspagliesi
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Dipartimento di Ginecologia Oncologica
Contact Person Name
Nicoletta Colombo
Contact Person Email
nicoletta.colombo@ieo.it
Site Name
Azienda Sanitaria Locale Br
Department Name
UOC Oncologia Medica
Contact Person Name
Saverio Cinieri
Contact Person Email
saverio.cinieri@gmail.com
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Oncologia Medica Provinciale
Contact Person Name
Alessandra Bologna
Contact Person Email
alessandra.bologna@ausl.re.it
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
Divisione di Ostetricia e Ginecologia
Contact Person Name
Annamaria Ferrero
Contact Person Email
annamaria.ferrero@unito.it
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia 2
Contact Person Name
Giulia Tasca
Contact Person Email
giulia.tasca@iov.veneto.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento di Ostetricia e Ginecologia
Contact Person Name
Alice Bergamini
Contact Person Email
bergamini.alice@hsr.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Gynecologic Oncology
Contact Person Name
Domenica Lorusso
Contact Person Email
domenica.lorusso@hunimed.eu
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Unità Operativa Complessa di Ginecologia Oncologica e Carcinoma Ovarico
Contact Person Name
Anna Fagotti
Site Name
Azienda Sanitaria Locale Della Provincia Di Biella
Department Name
S.O.C. Oncologia
Contact Person Name
Laura Zavallone

Greece

Earliest CTIS Part Ii Submission Date
21-03-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
353
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Areteio Hospital
Department Name
B’ Surgery Clinic - Oncology Unit
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Propaedeutic Internal Medicine Clinic & Research Unit - Oncology Unit
Contact Person Name
Amanda Psyrri
Contact Person Email
psyrri237@yahoo.com
Site Name
Alexandra Hospital
Department Name
Department of Clinical Therapeutics
Contact Person Name
Michalis Liontos
Contact Person Email
mliontos@gmail.com
Site Name
St. Luke's Hospital S.A.
Department Name
Oncology Department
Contact Person Name
Eleni Fountzila
Contact Person Email
elenafou@gmail.com

Norway

Earliest CTIS Part Ii Submission Date
17-04-2025
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
322
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Oslo University Hospital HF
Department Name
Department of Gynaecological Oncology
Contact Person Name
Kristina Lindemann
Contact Person Email
klinde@ous-hf.no
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Department of Oncology
Contact Person Name
Anne Gry Bentzen
Contact Person Email
Anne.gry.bentzen@unn.no

Denmark

Earliest CTIS Part Ii Submission Date
17-04-2025
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
323
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Rigshospitalet
Department Name
Department of Oncology
Contact Person Name
Trine Jakobi Nøttrup
Site Name
Odense University Hospital
Department Name
Department of Oncology
Contact Person Name
Anja Ør Knudsen
Contact Person Email
anja.oer.knudsen@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Department of Oncology
Contact Person Name
Charlotte Aaquist Haslund
Contact Person Email
cah@rn.dk

Netherlands

Earliest CTIS Part Ii Submission Date
14-02-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
388
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Medisch Spectrum Twente
Department Name
Medical Oncology
Contact Person Name
Machteld Wymenga
Contact Person Email
a.wymenga@mst.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Medical Oncology
Contact Person Name
Ingrid Boere
Contact Person Email
i.boere@erasmusmc.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Medical Oncology
Contact Person Name
Judith Kroep
Contact Person Email
j.r.kroep@lumc.nl
Site Name
Academisch Medisch Centrum
Department Name
Medical Oncology
Contact Person Name
Jasper Vleughels
Contact Person Email
j.l.vleughels@amsterdamumc.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Medical Oncology
Contact Person Name
Antoinetta Beijers
Contact Person Email
Tonneke.beijers@mumc.nl

Germany

Earliest CTIS Part Ii Submission Date
15-04-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
329
Number Of Sites
15
Number Of Participants
28

Sites

Site Name
MVZ Onko Medical GmbH
Department Name
Gynecology and obstretrics
Contact Person Name
Hans-Joachim Lueck
Contact Person Email
hlueck@goph.de
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin
Contact Person Name
Julia Radosa
Contact Person Email
Julia.Radosa@uks.eu
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Gynecologic Oncology
Contact Person Name
Katharina Smetanay
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Contact Person Name
Sabrine Kaiser
Contact Person Email
Sa.Kaiser@kem-med.com
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Gynecology and Obstetrics
Contact Person Name
Tanja Fehm
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Gynecology and Obstetrics
Contact Person Name
Ivo Meinhold-Heerlein
Site Name
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Michael Eichbaum
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Klinik fuer Gynaekologie und Geburtshilfe
Contact Person Name
Michael Untch
Site Name
Rotkreuzklinikum Muenchen gGmbH
Department Name
Gynecologic Oncology and Minimally-invasive Surgery
Contact Person Name
Martin Poelcher
Contact Person Email
martin.poelcher@swmbrk.de
Site Name
Mammazentrum Hamburg MVZ GbR
Department Name
Mammazentrum HH am Krankenhaus Jerusalem
Contact Person Name
Felix Hilpert
Contact Person Email
Studien@mammazentrum.eu
Site Name
Technische Universitaet Dresden
Department Name
Gynecology and Obstetrics
Contact Person Name
Pauline Wimberger
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik II
Contact Person Name
Maximilian Rost
Site Name
Universitaetsklinikum Essen AöR
Department Name
Gynecology and Obstetrics
Contact Person Name
Fabinshy Thangarajah
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik für Gynaekologie und gynaekologische Onkologie
Contact Person Name
Alexander Mustea
Contact Person Email
Alexander.Mustea@ukbonn.de
Site Name
Universitaet Muenster
Department Name
Gynecology and Obstetrics
Contact Person Name
Lars Christian Hanker
Contact Person Email
lars.hanker@uksh.de

Poland

Earliest CTIS Part Ii Submission Date
16-04-2025
Latest Decision Or Authorization Date
08-03-2026
Processing Time Days
326
Number Of Sites
9
Number Of Participants
19

Sites

Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Siedleckie Centrum Onkologii Oddział Onkologii Klinicznej i Radioterapii
Contact Person Name
Lubomir Bodnar
Contact Person Email
lbodnar@szpital.siedlce.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Położnictwa i Ginekologii, Ginekologii Onkologicznej i Endokrynologii Ginekologicznej
Contact Person Name
Dagmara Klasa-Mazurkiewicz
Contact Person Email
dklasa@gumed.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
Department Name
Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt
Contact Person Name
Anita Chudecka-Głaz
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Ginekologii Onkologicznej
Contact Person Name
Radosław Mądry
Contact Person Email
radoslaw.madry@skpp.edu.pl
Site Name
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Department Name
Odział Radioterapii i Onkologii Ginekologicznej
Contact Person Name
Bartosz Urbański
Contact Person Email
bartosz.urbanski@wco.pl
Site Name
Jagiellońskie Centrum Innowacji Sp. z o.o.
Department Name
Centrum Badań Klinicznych JCI
Contact Person Name
Paweł Blecharz
Contact Person Email
cbk@jci.pl
Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Klinika Onkologii
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddział Onkologii Ginekologicznej oraz Poradnia Ginekologii Onkologicznej
Contact Person Name
Beata Maćkowiak-Matejczyk
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Ginekologii Onkologicznej
Contact Person Name
Mariusz Bidziński
Contact Person Email
badaniakliniczne@nio-gov.pl

Austria

Earliest CTIS Part Ii Submission Date
07-04-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
336
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Medical University Of Vienna
Department Name
Gynecology and Obstetrics
Contact Person Name
Stephan Polterauer
Site Name
Medizinische Universitaet Innsbruck
Department Name
Gynecology and Obstetrics
Contact Person Name
Christian Marth
Site Name
Klinik Hietzing
Department Name
Department Gynecology and Obstetrics
Contact Person Name
Christian Peters-Engl
Site Name
Ordensklinikum Linz GmbH
Department Name
Gynecology and Obstetrics
Contact Person Name
Judith Lafleur
Site Name
Medical University Of Graz
Department Name
Department of Gynecology and Obstetrics
Contact Person Name
Gerda Trutnovsky
Contact Person Email
Gerda.trutnovsky@medunigraz.at

Spain

Earliest CTIS Part Ii Submission Date
04-04-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
339
Number Of Sites
9
Number Of Participants
15

Sites

Site Name
Hospital Universitario Miguel Servet
Department Name
Oncology
Contact Person Name
Eugenia Ortega Izquierdo
Contact Person Email
eugeniaortegai@hotmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Purificación Estévez García
Contact Person Email
puriestevez@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Contact Person Name
Andrés Redondo Sánchez
Contact Person Email
Aredondo12@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Medical Oncology
Contact Person Name
María Quindós Varela
Contact Person Email
maria.quindos.varela@sergas.es
Site Name
MD Anderson Cancer Center
Department Name
Oncology
Contact Person Name
Raúl Márquez Vázquez
Contact Person Email
raulmarquez@mdanderson.es
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Contact Person Name
Ignacio Romero Noguera
Contact Person Email
iromero@fivo.org
Site Name
Hospital Universitario Donostia
Department Name
Medical Oncology
Contact Person Name
Cristina Churruca Gálaz
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Oncology
Contact Person Name
Ana Puertes Boix
Contact Person Email
ana.puertes@carm.es
Site Name
Hospital Universitario La Paz (duplicate listing if present)
Department Name
Oncology

France

Earliest CTIS Part Ii Submission Date
03-04-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
344
Number Of Sites
7
Number Of Participants
14

Sites

Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Contact Person Name
Jean-Sebastien Frenel
Site Name
Hospices Civils De Lyon
Department Name
Medical Oncology
Contact Person Name
Benoit You
Contact Person Email
benoit.you@chu-lyon.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncology
Contact Person Name
Thibault DE LA MOTTE ROUGE
Site Name
Institut Gustave Roussy
Department Name
Département d’Innovation Thérapeutique et des Essais Précoces (DITEP)
Contact Person Name
Kaissa OUALI
Contact Person Email
Kaissa.ouali@gustaveroussy.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Medical Oncology
Contact Person Name
Claire Gervais
Contact Person Email
claire.gervais@aphp.fr
Site Name
Centre Antoine Lacassagne
Department Name
Medical Oncology
Contact Person Name
Philippe Follana
Site Name
Oncopole Claudius Regaud
Department Name
Medical Oncology Department
Contact Person Name
Laurence Gladieff

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
codes: 1,12,13,14,4,5,6,7,8
Name
PRA Hellas CRO A.E.
Responsibilities
codes: 1,12,13,14,4,5,6,7,8
Name
IQVIA Limited
Responsibilities
code: 4
Name
WCG Clinical Inc.
Responsibilities
code: 10
Name
Medidata Solutions Inc.
Responsibilities
code: 7

Third parties

  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient support services","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Austria","full_name":"Medizinische Universitaet Innsbruck","duties_or_roles":"code: 4","organisation_type":"Educational Institution"}
  • {"country":"United States","full_name":"Edetek Inc.","duties_or_roles":"code: 10","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"code: 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"code: 10","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes: 1,12,13,14,4,5,6,7,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"code: 6","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging (code: 15)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"codes: 1,12,13,14,4,5,6,7,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"code: 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"code: 4","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
Investigational Product Name
PACLITAXEL
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Maximum Dose
80 mg/m2
Investigational Product Name
GEMCITABINE
Active Substance
GEMCITABINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Maximum Dose
1000 mg/m2
Investigational Product Name
DOXORUBICIN
Active Substance
DOXORUBICIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Maximum Dose
40 mg/m2
Investigational Product Name
TOPOTECAN
Active Substance
TOPOTECAN
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Maximum Dose
4 mg/m2
Investigational Product Name
PEGFILGRASTIM
Active Substance
GLATIRAMER ACETATE
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous use
Route
Subcutaneous

Related trials

Other published trials that may interest you.