Clinical trial • Phase III • Oncology

AZD5335 for Advanced platinum-resistant epithelial ovarian cancer | High-grade serous epithelial ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer

Phase III trial of AZD5335 for Advanced platinum-resistant epithelial ovarian cancer | High-grade serous epithelial ovarian cancer | Primary peritoneal ca…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced platinum-resistant epithelial ovarian cancer | High-grade serous epithelial ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer
Trial Stage
Phase III
Drug Modality
ADC | Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
26-11-2025
First CTIS Authorization Date
27-03-2026

Trial design

Randomised, open-label, mirvetuximab soravtansine (mirv) iv (active comparator in frα-high cohort; product record shows dose 6 mg/kg iv listed) ; investigator's choice chemotherapy (active comparator in frα-low cohort): single-agent paclitaxel iv (dose units mg/m2; product record shows max daily 80 mg/m2, max total 320 mg/m2), pegylated liposomal doxorubicin (doxorubicin hydrochloride, liposomal) iv (dose units mg/m2; product record shows max daily 40 mg/m2), or topotecan iv (dose units mg/m2; product record shows max daily 4 mg/m2, max total 12 mg/m2). schedules described as intravenous infusion; detailed administration schedule not provided in the available data.-controlled Phase III trial across 80 sites in Belgium, Czechia, Denmark and others.

Randomised
Yes
Open Label
Yes
Comparator
Mirvetuximab Soravtansine (MIRV) IV (active comparator in FRα-high cohort; product record shows dose 6 mg/kg IV listed) ; Investigator's choice chemotherapy (active comparator in FRα-low cohort): single-agent Paclitaxel IV (dose units mg/m2; product record shows max daily 80 mg/m2, max total 320 mg/m2), Pegylated liposomal Doxorubicin (Doxorubicin hydrochloride, liposomal) IV (dose units mg/m2; product record shows max daily 40 mg/m2), or Topotecan IV (dose units mg/m2; product record shows max daily 4 mg/m2, max total 12 mg/m2). Schedules described as intravenous infusion; detailed administration schedule not provided in the available data.
Biomarker Stratified
True, biomarker: FRα (folate receptor alpha); strata: FRα-high vs FRα-low
Target Sample Size
791
Trial Duration For Participant
1488

Eligibility

Recruits 791 Vulnerable population selected (isVulnerablePopulationSelected = true). Trial enrols adult female participants only. Informed consent is required from participants; no assent/parental consent procedures for minors are specified in the available materials..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Trial enrols adult female participants only. Informed consent is required from participants; no assent/parental consent procedures for minors are specified in the available materials.

Inclusion criteria

  • {"criterion_text":"- 1. Participants with confirmed diagnosis of high-grade serous EOC, primaryperitoneal cancer, or fallopian tube cancer.\n- 2. Participants must have platinum-resistant disease: a) Participants who have only had one prior line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between > 3 months and ≤ 6 months after the date of the last dose of platinum. b) Participants who have received 2 or 3 lines of platinum therapy must have progressed ≤ 6 months after the date of the last dose of platinum.\n- 3. Participants must have radiologically progressed on or after their most recent line of therapy.\n- 4. Participants must have received at least one, but no more than 3, prior systemic lines of anti-cancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment\n- 5. Participants with documented BRCA mutation (germline and/or somatic) must have received prior PARPi if the participant is eligible per approved label and standard-of-care institutional guidelines, except in cases of documented contraindication,precaution or intolerance\n- 6. Provision of an FFPE tumour tissue sample"}

Exclusion criteria

  • {"criterion_text":"- 1. Participants with endometrioid, clear cell, mucinous, or sarcomatous histology,mixed tumours containing any of the above histologies, or low-grade or borderline ovarian tumour.\n- 2. Primary platinum-refractory disease, defined as disease that did not respond to or has progressed ≤ 3 months after the last dose of first line platinum-containingchemotherapy.\n- 3. Participants with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring\n- 4. Current signs, symptoms, or clinical investigations consistent with bowel obstruction, including sub-occlusive disease.\n- 5. Participant has non-infectious ILD/pneumonitis or has a history of non-infectious ILD/pneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.\n- 6. Prior treatment with any FRα-targeted therapy, including MIRV, or any TOP1i ADC.\n- 7. Major surgical procedure within 4 weeks of the first dose of study intervention"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression free Survival (PFS): PFS is defined as the time from randomization to radiographic progression as assessed by the Investigator per RECIST v1.1, or death due to any cause.","definition_or_measurement_approach":"PFS is defined as the time from randomization to radiographic progression as assessed by the Investigator per RECIST v1.1, or death due to any cause."}

Secondary endpoints

  • {"endpoint_text":"- Overall survival (OS): OS is defined as the time from randomisation until the date of death due to any cause.","definition_or_measurement_approach":"OS is defined as the time from randomisation until the date of death due to any cause."}

Recruitment

Planned Sample Size
791
Recruitment Window Months
48
Consent Approach
Informed consent is required from adult participants. Country-specific subject information and informed consent forms are provided (documents available in multiple languages including English, French, Dutch, German, Czech, Spanish, Italian, Greek, Swedish, Danish). Separate ICFs for pregnancy and optional genomics/future research are available. No assent/parental consent procedures for minors are described in the available documentation.

Geography

Total Number Of Sites
80
Total Number Of Participants
309

Belgium

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
4
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
UZ Leuven
Department Name
Gynaecological oncology
Principal Investigator Name
Toon Van Gorp
Principal Investigator Email
TOON.VANGORP@UZLEUVEN.BE
Contact Person Name
Toon Van Gorp
Contact Person Email
TOON.VANGORP@UZLEUVEN.BE
Site Name
Universitair Ziekenhuis Gent
Department Name
Medical Oncology
Principal Investigator Name
Hannelore Denys
Principal Investigator Email
hannelore.denys@ugent.be
Contact Person Name
Hannelore Denys
Contact Person Email
hannelore.denys@ugent.be
Site Name
Grand Hopital De Charleroi
Department Name
Oncology
Principal Investigator Name
Alix Devaux
Principal Investigator Email
alix.devaux@ghdc.be
Contact Person Name
Alix Devaux
Contact Person Email
alix.devaux@ghdc.be
Site Name
Hopital De Libramont
Department Name
Oncology
Principal Investigator Name
Frédéric Forget
Principal Investigator Email
Frederic.Forget@vivalia.be
Contact Person Name
Frédéric Forget
Contact Person Email
Frederic.Forget@vivalia.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Oncology
Principal Investigator Name
Stephanie Henry
Principal Investigator Email
stephanie.henry@chuuclnamur.uclouvain.be
Contact Person Name
Stephanie Henry
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Oncology
Principal Investigator Name
Sevilay Altintas
Principal Investigator Email
sevilay.altintas@uza.be
Contact Person Name
Sevilay Altintas
Contact Person Email
sevilay.altintas@uza.be

Czechia

Earliest CTIS Part Ii Submission Date
09-03-2026
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
21
Number Of Sites
7
Number Of Participants
30

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
Clinic of gynecology and obstetrics
Principal Investigator Name
Markéta Bednaříková
Principal Investigator Email
bednarikova.marketa@fnbrno.cz
Contact Person Name
Markéta Bednaříková
Contact Person Email
bednarikova.marketa@fnbrno.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Gynecological and obstetrics clinic
Principal Investigator Name
Ivan Práznovec
Principal Investigator Email
ivan.praznovec@fnhk.cz
Contact Person Name
Ivan Práznovec
Contact Person Email
ivan.praznovec@fnhk.cz
Site Name
University Hospital Olomouc
Department Name
Oncology clinic
Principal Investigator Name
Bohuslav Melichar
Principal Investigator Email
bohuslav.melichar@fnol.cz
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Department of Radiotherapy and Oncology
Principal Investigator Name
Vojtěch Tlustý
Principal Investigator Email
vojtech.tlusty@nnj.agel.c
Contact Person Name
Vojtěch Tlustý
Contact Person Email
vojtech.tlusty@nnj.agel.c
Site Name
Fakultni Nemocnice Bulovka
Department Name
Gynecological and obstetrics clinic
Principal Investigator Name
Michal Zikán
Principal Investigator Email
michal.zikan@bulovka.cz
Contact Person Name
Michal Zikán
Contact Person Email
michal.zikan@bulovka.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Oncology clinic
Principal Investigator Name
Anna Nohejlová Medková
Principal Investigator Email
anna.nohejlova@fnmotol.cz
Contact Person Name
Anna Nohejlová Medková
Contact Person Email
anna.nohejlova@fnmotol.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Clinic of Gynecology, Obstetrics and Neonatology
Principal Investigator Name
David Cibula
Principal Investigator Email
david.cibula@vfn.cz
Contact Person Name
David Cibula
Contact Person Email
david.cibula@vfn.cz

Denmark

Earliest CTIS Part Ii Submission Date
25-03-2026
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
5
Number Of Sites
4
Number Of Participants
19

Sites

Site Name
Region Midtjylland
Department Name
Department of Oncology
Principal Investigator Name
Sarah Steen
Principal Investigator Email
sarah.steen@auh.rm.dk
Contact Person Name
Sarah Steen
Contact Person Email
sarah.steen@auh.rm.dk
Site Name
Aalborg University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Anne Krejbjerg
Principal Investigator Email
anne.krejbjerg@rn.dk
Contact Person Name
Anne Krejbjerg
Contact Person Email
anne.krejbjerg@rn.dk
Site Name
Odense University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Trine Lembrecht Jørgensen
Principal Investigator Email
trine.joergensen@rsyd.dk
Contact Person Name
Trine Lembrecht Jørgensen
Contact Person Email
trine.joergensen@rsyd.dk
Site Name
Sygehus Lillebaelt Vejle Sygehus
Department Name
Department of Oncology
Principal Investigator Name
Caroline Brenner Thomsen
Principal Investigator Email
caroline.emilie.brenner.thomsen@rsyd.dk
Contact Person Name
Caroline Brenner Thomsen

Greece

Earliest CTIS Part Ii Submission Date
10-12-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
110
Number Of Sites
3
Number Of Participants
40

Sites

Site Name
Areteio Hospital
Department Name
2nd Surgical Department, Oncology Unit
Principal Investigator Name
Flora Zagouri
Principal Investigator Email
florazagouri@yahoo.co.uk
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
General Hospital Of Athens Alexandra
Department Name
Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, National & Kapodistrian University
Principal Investigator Name
Michael Liontos
Principal Investigator Email
liontos@gmail.com
Contact Person Name
Michael Liontos
Contact Person Email
liontos@gmail.com
Site Name
St. Luke's Hospital S.A.
Department Name
Department of Medical Oncology
Principal Investigator Name
Eleni Fountzila
Principal Investigator Email
elenafou@gmail.com
Contact Person Name
Eleni Fountzila
Contact Person Email
elenafou@gmail.com

Ireland

Earliest CTIS Part Ii Submission Date
02-03-2026
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
31
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Cork University Hospital
Department Name
Oncology
Principal Investigator Name
Dearbhaile Collins
Principal Investigator Email
Dearbhaile.Collins@hse.ie
Contact Person Name
Dearbhaile Collins
Contact Person Email
Dearbhaile.Collins@hse.ie
Site Name
St Vincent's University Hospital
Department Name
Oncology
Principal Investigator Name
Lynda McSorely
Principal Investigator Email
lyndamcsorley@svhg.ie
Contact Person Name
Lynda McSorely
Contact Person Email
lyndamcsorley@svhg.ie
Site Name
University Hospital Waterford
Department Name
Oncology
Principal Investigator Name
Paula M. Calvert
Principal Investigator Email
PaulaM.Calvert@hse.ie
Contact Person Name
Paula M. Calvert
Contact Person Email
PaulaM.Calvert@hse.ie
Site Name
St James's Hospital
Department Name
Oncology
Principal Investigator Name
Karen Cadoo
Principal Investigator Email
KCadoo@stjames.ie
Contact Person Name
Karen Cadoo
Contact Person Email
KCadoo@stjames.ie
Site Name
Mater Misericordiae University Hospital
Department Name
Oncology
Principal Investigator Name
Donal Brennan
Principal Investigator Email
donal.brennan@ucd.ie
Contact Person Name
Donal Brennan
Contact Person Email
donal.brennan@ucd.ie

Italy

Earliest CTIS Part Ii Submission Date
05-02-2026
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
54
Number Of Sites
11
Number Of Participants
35

Sites

Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Obstetrics and Gynecology
Principal Investigator Name
Germana Tognon
Principal Investigator Email
germanatognon@gmail.com
Contact Person Name
Germana Tognon
Contact Person Email
germanatognon@gmail.com
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
SC Oncologia Falck
Principal Investigator Name
Giulia Carlo Stella
Principal Investigator Email
giulia.carlostella@ospedaleniguarda.it
Contact Person Name
Giulia Carlo Stella
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Medical Oncology 1
Principal Investigator Name
Carmelo Bengala
Principal Investigator Email
carmelo.bengala@ao-pisa.toscana.it
Contact Person Name
Carmelo Bengala
Site Name
Azienda Ospedaliera Ordine Mauriziano Torino
Department Name
Academic Department Gynecology and Obstetrics
Principal Investigator Name
Annamaria Ferrero
Principal Investigator Email
a.ferrero0505@gmail.com
Contact Person Name
Annamaria Ferrero
Contact Person Email
a.ferrero0505@gmail.com
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Ginecologia Oncologica
Principal Investigator Name
Vanda Salutari
Principal Investigator Email
vanda.salutari@policlinicogemelli.it
Contact Person Name
Vanda Salutari
Site Name
Alessandro Manzoni Hospital
Department Name
Oncology
Principal Investigator Name
Federica Villa
Principal Investigator Email
fe.villa@asst-lecco.it
Contact Person Name
Federica Villa
Contact Person Email
fe.villa@asst-lecco.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Gynecologic Oncology
Principal Investigator Name
Domenica Lorusso
Principal Investigator Email
domenica.lorusso@hunimed.eu
Contact Person Name
Domenica Lorusso
Contact Person Email
domenica.lorusso@hunimed.eu
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Gynecological Oncology
Principal Investigator Name
Nicoletta Colombo
Principal Investigator Email
nicoletta.colombo@ieo.it
Contact Person Name
Nicoletta Colombo
Contact Person Email
nicoletta.colombo@ieo.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Ginecologia Chirurgica ed Oncologica
Principal Investigator Name
Federica Tomao
Principal Investigator Email
federica.tomao@uniroma1.it
Contact Person Name
Federica Tomao
Contact Person Email
federica.tomao@uniroma1.it
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
DEPARTMENT OF MEDICAL ONCOLOGY VIA GRAMSCI, 14 43126 PARMA (PR),
Principal Investigator Name
Angelica Sikokis
Principal Investigator Email
asikokis@ao.pr.it
Contact Person Name
Angelica Sikokis
Contact Person Email
asikokis@ao.pr.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Gynecological Medical Oncology
Principal Investigator Name
Maria Cristina Petrella
Principal Investigator Email
mariacristina.petrella@gmail.com
Contact Person Name
Maria Cristina Petrella

Spain

Earliest CTIS Part Ii Submission Date
04-03-2026
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
27
Number Of Sites
10
Number Of Participants
33

Sites

Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Principal Investigator Name
Maria Jesus Rubio Perez
Principal Investigator Email
mjesusrubio63@gmail.com
Contact Person Name
Maria Jesus Rubio Perez
Contact Person Email
mjesusrubio63@gmail.com
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Oncology
Principal Investigator Name
Pau Guillen Sentis
Principal Investigator Email
pguillens@iconcologia.net
Contact Person Name
Pau Guillen Sentis
Contact Person Email
pguillens@iconcologia.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
Alfonso Cortes Salgado
Principal Investigator Email
csalgado86@gmail.com
Contact Person Name
Alfonso Cortes Salgado
Contact Person Email
csalgado86@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Principal Investigator Name
María Quindós Varela
Principal Investigator Email
mariaquindosvarela@hotmail.com
Contact Person Name
María Quindós Varela
Contact Person Email
mariaquindosvarela@hotmail.com
Site Name
Hospital Universitario Donostia
Department Name
Oncology
Principal Investigator Name
Cristina Churruca Galaz
Principal Investigator Email
CRISTINAMARIA.CHURRUCAGALAZ@osakidetza.eus
Contact Person Name
Cristina Churruca Galaz
Site Name
Institut Catala D'oncologia (L'Hospitalet)
Department Name
Oncology
Principal Investigator Name
Beatriz Pardo Burdalo
Principal Investigator Email
bpardo@iconcologia.net
Contact Person Name
Beatriz Pardo Burdalo
Contact Person Email
bpardo@iconcologia.net
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Oncology
Principal Investigator Name
Pilar Barretina Ginesta
Principal Investigator Email
mpbarretina@iconcologia.net
Contact Person Name
Pilar Barretina Ginesta
Contact Person Email
mpbarretina@iconcologia.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Luis Manso Sanchez
Principal Investigator Email
luismansosanchez@gmail.com
Contact Person Name
Luis Manso Sanchez
Contact Person Email
luismansosanchez@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Lydia Gaba Garcia
Principal Investigator Email
LGABA@clinic.cat
Contact Person Name
Lydia Gaba Garcia
Contact Person Email
LGABA@clinic.cat
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Principal Investigator Name
Jose Alejandro Perez Fidalgo
Principal Investigator Email
japfidalgo@msn.com
Contact Person Name
Jose Alejandro Perez Fidalgo
Contact Person Email
japfidalgo@msn.com

Sweden

Earliest CTIS Part Ii Submission Date
20-03-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
7
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Department of Hematology, oncology and radiation physics
Principal Investigator Name
Susanne Malander
Principal Investigator Email
susanne.malander@med.lu.se
Contact Person Name
Susanne Malander
Contact Person Email
susanne.malander@med.lu.se
Site Name
Karolinska University Hospital
Department Name
Department of Pelvic cancer
Principal Investigator Name
Josefin Fernebro
Principal Investigator Email
josefin.fernebro@regionstockholm.se
Contact Person Name
Josefin Fernebro
Site Name
Uppsala University Hospital
Department Name
Department of Hematology, Oncology and Endocrine tumors
Principal Investigator Name
Camilla Sköld
Principal Investigator Email
camilla.skold@igp.uu.se
Contact Person Name
Camilla Sköld
Contact Person Email
camilla.skold@igp.uu.se
Site Name
Region Oestergoetland
Department Name
Dept of Oncology
Principal Investigator Name
Gabriel Lindahl
Principal Investigator Email
gabriel.lindahl@regionostergotland.se
Contact Person Name
Gabriel Lindahl

France

Earliest CTIS Part Ii Submission Date
16-03-2026
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
58
Number Of Sites
13
Number Of Participants
48

Sites

Site Name
Institut Curie
Department Name
Medical Oncology
Principal Investigator Name
Manuel Rodrigues
Principal Investigator Email
manuel.rodrigues@curie.fr
Contact Person Name
Manuel Rodrigues
Contact Person Email
manuel.rodrigues@curie.fr
Site Name
Centre Hospitalier De Dax Cote D'Argent
Department Name
Oncology
Principal Investigator Name
Mottet Thibaut
Principal Investigator Email
Thibaut.mottet@ch-dax.fr
Contact Person Name
Mottet Thibaut
Contact Person Email
Thibaut.mottet@ch-dax.fr
Site Name
CARIO Centre Armoricain de Radiotherapie D'Imagerie medicale et D'Oncologie
Department Name
Oncology
Principal Investigator Name
Fanny Derquin
Principal Investigator Email
f.derquin@cario-sante.fr
Contact Person Name
Fanny Derquin
Contact Person Email
f.derquin@cario-sante.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Principal Investigator Name
Jean-Sébastien Frenel
Principal Investigator Email
jean-sebastien.frenel@ico.unicancer.fr
Contact Person Name
Jean-Sébastien Frenel
Site Name
Hospices Civils De Lyon
Department Name
Medical Oncology
Principal Investigator Name
Benoit You
Principal Investigator Email
benoit.you@chu-lyon.fr
Contact Person Name
Benoit You
Contact Person Email
benoit.you@chu-lyon.fr
Site Name
Clinique Pasteur
Department Name
Medical Oncology
Principal Investigator Name
Mathilde Martinez
Principal Investigator Email
m.martinez@clinique-pasteur.com
Contact Person Name
Mathilde Martinez
Site Name
Oncoradio Centre Oncogard
Department Name
Medical Oncology
Principal Investigator Name
Delphine Duliege
Principal Investigator Email
duliege.delphine@chu-nimes.fr
Contact Person Name
Delphine Duliege
Contact Person Email
duliege.delphine@chu-nimes.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Medical Oncology
Principal Investigator Name
Aurelie Moreira
Principal Investigator Email
moreira.aurelie@chu-amiens.fr
Contact Person Name
Aurelie Moreira
Contact Person Email
moreira.aurelie@chu-amiens.fr
Site Name
Institut Godinot
Department Name
Medical Oncology
Principal Investigator Name
Pierre Martin
Principal Investigator Email
pierre.martin@reims.unicancer.fr
Contact Person Name
Pierre Martin
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Oncology
Principal Investigator Name
Pauline Corbaux
Principal Investigator Email
Pauline.CORBAUX@chu-st-etienne.fr
Contact Person Name
Pauline Corbaux
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Medical Oncology
Principal Investigator Name
Hélène Vegas
Principal Investigator Email
h.vegas@chu-tours.fr
Contact Person Name
Hélène Vegas
Contact Person Email
h.vegas@chu-tours.fr
Site Name
Centre Hospitalier De Pau
Department Name
Oncology
Principal Investigator Name
Kévin Bourcier
Principal Investigator Email
kevin.bourcier@ch-pau.fr
Contact Person Name
Kévin Bourcier
Contact Person Email
kevin.bourcier@ch-pau.fr
Site Name
Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name
Medical Oncology
Principal Investigator Name
Julien Genier
Principal Investigator Email
j.grenier@isc84.org
Contact Person Name
Julien Genier
Contact Person Email
j.grenier@isc84.org

Germany

Earliest CTIS Part Ii Submission Date
09-03-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
65
Number Of Sites
17
Number Of Participants
38

Sites

Site Name
Medizinische Hochschule Hannover
Department Name
gynaecologic oncology
Principal Investigator Name
Tjoung-Won Park-Simon
Principal Investigator Email
Park-Simon.Tjoung-Won@mh-hannover.de
Contact Person Name
Tjoung-Won Park-Simon
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
gynaecologic oncology
Principal Investigator Name
Frederik Marmé
Principal Investigator Email
frederik.marme@umm.de
Contact Person Name
Frederik Marmé
Contact Person Email
frederik.marme@umm.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Obstetrics and Gynecology
Principal Investigator Name
Tanja Fehm
Principal Investigator Email
studien.fehm@med.uni-duesseldorf.de
Contact Person Name
Tanja Fehm
Site Name
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Department Name
gynaecologic oncology
Principal Investigator Name
Lena Pfaff
Principal Investigator Email
Lena.Pfaff@rbk.de
Contact Person Name
Lena Pfaff
Contact Person Email
Lena.Pfaff@rbk.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
gynaecologic oncology
Principal Investigator Name
Lucia Otten
Principal Investigator Email
lucia.otten@ukbonn.de
Contact Person Name
Lucia Otten
Contact Person Email
lucia.otten@ukbonn.de
Site Name
Universitaet Leipzig
Department Name
gynaecology and obstetric
Principal Investigator Name
Bahriye Aktas
Principal Investigator Email
bahriye.aktas@medizin.uni-leipzig.de
Contact Person Name
Bahriye Aktas
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
gynaecologic oncology
Principal Investigator Name
Elena Ioana Braicu
Principal Investigator Email
elena.braicu@charite.de
Contact Person Name
Elena Ioana Braicu
Contact Person Email
elena.braicu@charite.de
Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
gynaecologic oncology
Principal Investigator Name
Marc Thill
Principal Investigator Email
marc.thill@agaplesion.de
Contact Person Name
Marc Thill
Contact Person Email
marc.thill@agaplesion.de
Site Name
Technische Universitaet Dresden
Department Name
gynaecologic oncology
Principal Investigator Name
Pauline Wimberger
Principal Investigator Email
Pauline.Wimberger@ukdd.de
Contact Person Name
Pauline Wimberger
Contact Person Email
Pauline.Wimberger@ukdd.de
Site Name
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Department Name
gynaecologic oncology
Principal Investigator Name
Michael Eichbaum
Principal Investigator Email
michael.eichbaum@helios-gesundheit.de
Contact Person Name
Michael Eichbaum
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
gynaecologic oncology
Principal Investigator Name
Tobias Engler
Principal Investigator Email
Tobias.Engler@med.uni-tuebingen.de
Contact Person Name
Tobias Engler
Site Name
Albertinen-Krankenhaus/Albertinen-Haus gGmbH
Department Name
gynaecologic oncology
Principal Investigator Name
Ulrike Doerste
Principal Investigator Email
ulrike.doerste@immanuelalbertinen.de
Contact Person Name
Ulrike Doerste
Site Name
Universitaetsklinikum Ulm AöR
Department Name
gynaecologic oncology
Principal Investigator Name
Sabine Heublein
Principal Investigator Email
sabine.heublein@uniklinik-ulm.de
Contact Person Name
Sabine Heublein
Site Name
DIAK Klinikum Landkreis Schwaebisch Hall gGmbH
Department Name
gynaecologic oncology
Principal Investigator Name
Suzana Mittelstadt
Principal Investigator Email
suzana.mittelstadt@diak-klinikum.de
Contact Person Name
Suzana Mittelstadt
Site Name
Klinikum Lippe GmbH
Department Name
gynaecology and gynaecologic oncology
Principal Investigator Name
Beyhan Ataseven
Principal Investigator Email
Beyhan.Ataseven@klinikum-lippe.de
Contact Person Name
Beyhan Ataseven
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
gynaecologic oncology
Principal Investigator Name
Philipp Harter
Principal Investigator Email
p.harter@kem-med.com
Contact Person Name
Philipp Harter
Contact Person Email
p.harter@kem-med.com
Site Name
Universitaetsklinikum Essen AöR
Department Name
gynaecologic oncology
Principal Investigator Name
Fabinshy Thangarajah
Principal Investigator Email
fabinshy.thangarajah@uk-essen.de
Contact Person Name
Fabinshy Thangarajah

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Contract research organisations

Name
Fortrea Development Ltd. Branch Of Foreign Company
Responsibilities
codes: 1,12,2,7
Name
Fortrea Inc.
Responsibilities
codes: 1,10,11,12,13,2,3,5,6,7,8

Third parties

  • {"country":"Greece","full_name":"Fortrea Development Ltd. Branch Of Foreign Company","duties_or_roles":"codes: 1,12,2,7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"codes: 1,10,11,12,13,2,3,5,6,7,8","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
AZD5335
Active Substance
AZD5335
Modality
ADC
Routes Of Administration
IV INFUSION
Route
IV
Authorisation Status
prodAuthStatus=1
Investigational Product Name
MIRVETUXIMAB SORAVTANSINE
Active Substance
Mirvetuximab soravtansine
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
IV
Authorisation Status
prodAuthStatus=2
Orphan Designation
Yes
Maximum Dose
6 mg/kg
Investigational Product Name
PACLITAXEL
Active Substance
Paclitaxel
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
IV
Authorisation Status
prodAuthStatus=2
Maximum Dose
max daily 80 mg/m2; max total 320 mg/m2
Investigational Product Name
DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL
Active Substance
Doxorubicin hydrochloride, liposomal
Modality
Small molecule
Routes Of Administration
IV INFUSION
Route
IV
Authorisation Status
prodAuthStatus=2
Maximum Dose
40 mg/m2
Investigational Product Name
TOPOTECAN
Active Substance
Topotecan
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
IV
Authorisation Status
prodAuthStatus=2
Maximum Dose
max daily 4 mg/m2; max total 12 mg/m2

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