Clinical trial • Phase II/III • Oncology

IZALONTAMAB BRENGITECAN for Breast cancer | Triple-negative breast cancer

Phase II/III trial of IZALONTAMAB BRENGITECAN for Breast cancer | Triple-negative breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Breast cancer | Triple-negative breast cancer
Trial Stage
Phase II/III
Drug Modality
ADC | Small molecule | Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
04-07-2025
First CTIS Authorization Date
17-10-2025

Trial design

Randomised, open-label, treatment of physician's choice (tpc) options: paclitaxel; nab‑paclitaxel (paclitaxel albumin‑bound); capecitabine; or carboplatin plus gemcitabine. doses and schedules not specified in the ctis part i/part ii product listings.-controlled, adaptive Phase II/III trial across 86 sites in Austria, France, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Treatment of Physician's Choice (TPC) options: paclitaxel; nab‑paclitaxel (paclitaxel albumin‑bound); capecitabine; or carboplatin plus gemcitabine. Doses and schedules not specified in the CTIS Part I/Part II product listings.
Adaptive
True — inferentially seamless Phase 2/3 design with dose-finding/selection elements (study objectives and secondary objectives reference comparison of two different doses and selection of appropriate dose to carry forward from Phase 2 to Phase 3). Interim/transition elements implied by the "inferentially seamless" design and dose selection objectives.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
341

Eligibility

Recruits 341 No vulnerable population selected; participants are adults only. Informed consent is obtained from participants (adult consent). No assent procedures or other vulnerable-population consent handling are described in the available CTIS data..

Vulnerable Population
No vulnerable population selected; participants are adults only. Informed consent is obtained from participants (adult consent). No assent procedures or other vulnerable-population consent handling are described in the available CTIS data.

Inclusion criteria

  • {"criterion_text":"- Participants who have advanced TNBC or ER-low, HER2-negative BC that can't be removed by surgery or has spread to other parts of the body, and have not received prior treatments at this stage of their disease\n- Participants must have completed all prior local cancer treatments at least 2 weeks prior to randomization (ie, radiotherapy and major surgery).\n- Participants with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 (eg, pembrolizumab) or an anti-PD-L1 (eg, atezolizumab).\n- Participants with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.\n- No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie, in the incurable setting).\n- Measurable disease by CT or MRI as per RECIST v1.1. Bone-only disease is allowed provided it is measurable (ie, with soft tissue component). Note: If there is only one measurable lesion, and if a biopsy is performed on that lesion, baseline imaging should be performed at least 14 days after the biopsy.\n- Participants must have MRI of the brain within 28 days prior to randomization. CT scan can be used in the presence of contraindication to MRI (eg, pacemaker).\n- Eligible for at least 1 of the chemotherapy options listed as TPC (paclitaxel, nab-paclitaxel, capecitabine, or carboplatin plus gemcitabine) per investigator assessment.\n- ECOG performance status of 0 or 1.\n- Recovered from all toxicities from previous systemic therapies to Grade 1 or less by NCI CTCAE v5.0 (except alopecia or peripheral neuropathy that may be Grade 2 or less) at the time of randomization."}

Exclusion criteria

  • {"criterion_text":"- Participants with a known germline BRCA 1 or 2 mutation whose best 1L treatment option, in the opinion of the investigator, is a PARPi.\n- Untreated symptomatic central nervous system (CNS) metastases. Participants are eligible if CNS metastases have been treated, and participants’ neurological signs and symptoms have returned to baseline. In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization. Imaging performed within 28 days of randomization must document radiographic stability of CNS lesions and be performed after completion of any CNS directed therapy.\n- Leptomeningeal metastases.\n- Active viral hepatitis\n- Other clinically active infectious liver disease including co-infection with hepatitis B and C/D (either known or detected reflexively in a patient with stable HBV infection).\n- Known uncontrolled HIV infection.\n- Participants with known bleeding coagulation disorders, including but not limited to hemophilia, von Willebrand disease, or any other coagulopathies that may affect blood clotting.\n- Prior history of clinically significant bleeding, intestinal obstruction, or perforation of the gastrointestinal tract within 3 months of randomization that has not recovered to Grade <1.\n- Infection requiring antibiotic use within 1 week prior to randomization."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS (progression-free survival) by BICR (Blinded Independent Central Review) The ability of iza-bren to work better than other common treatments chosen by the doctors is tested by looking at the PFS, which shows how long it takes for the disease to get worse by radiographic imaging techniques (like CT scans).","definition_or_measurement_approach":"Progression-free survival assessed by Blinded Independent Central Review (BICR); measured as time until disease progression by radiographic imaging (e.g., CT scans) per RECIST v1.1."}

Secondary endpoints

  • {"endpoint_text":"- This study will assess if people live longer when they take iza-bren compared to other treatments chosen by the doctors. This is what is called \"Overall Survival\"","definition_or_measurement_approach":"Overall Survival (OS): time from randomization to death from any cause."}

Recruitment

Digital Remote Recruitment
True — sponsor third-party vendors provide electronic study-related communications and eCOA/ePRO/data management platforms (e.g., Greenphire: electronic payments/travel arrangements/electronic study-related communications; Signant Health: PRO/COA; Medidata: Data Management Platform), indicating use of electronic communications and digital platforms to engage/communicate with patients.
Planned Sample Size
341
Recruitment Window Months
64
Consent Approach
Informed consent obtained via country-specific Subject Information Sheets (SIS) and Informed Consent Forms (ICF). Multiple country-language ICF/SIS documents are present (examples: AT, FR, DE, PT, ES, IT, GR, SE, PL, EN). Specific ICF versions for pregnant participants and pregnant partners, optional future research, and optional sample collection are included in the document set. Consent is provided by adult participants; no assent procedures described.

Methods

  • Patient brochure (K2) — country-specific patient brochure materials listed for multiple countries (e.g., AT, DE, GR, PT, IT, RO, ES, PL).
  • Patient invite letter (K2) — country-specific patient invitation letters are present (titles in document list).
  • HCP information letter to patient — clinician/HCP-delivered information materials to patients (document titles such as 'HCP information letter to patient').
  • Patient Visit Guide (K2) — patient-facing visit guidance materials listed for some countries.

Geography

Total Number Of Sites
86
Total Number Of Participants
159

Austria

Earliest CTIS Part Ii Submission Date
09-10-2025
Latest Decision Or Authorization Date
20-10-2025
Processing Time Days
11
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Medical University Of Vienna
Department Name
University Clinic for Internal Medicine I Clinical Department of Oncology
Principal Investigator Name
Rupert Bartsch
Principal Investigator Email
rupert.bartsch@meduniwien.ac.at
Contact Person Name
Rupert Bartsch
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
University Clinic for Internal Medicine III
Principal Investigator Name
Simon Gampenrieder
Principal Investigator Email
s.gampenrieder@salk.at
Contact Person Name
Simon Gampenrieder
Contact Person Email
s.gampenrieder@salk.at
Site Name
Medical University of Graz
Department Name
Department of Gynaecology and Obstetrics
Principal Investigator Name
Vassiliki Kolovetsiou-Kreiner
Principal Investigator Email
vassiliki.kolovetsiou@medunigraz.at
Contact Person Name
Vassiliki Kolovetsiou-Kreiner
Site Name
Medizinische Universitaet Innsbruck
Department Name
University Clinic for Gynecology and Obstetrics
Principal Investigator Name
Daniel Egle
Principal Investigator Email
daniel.egle@tirol-kliniken.at
Contact Person Name
Daniel Egle
Contact Person Email
daniel.egle@tirol-kliniken.at
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
Clinical Department of Internal Medicine 1
Principal Investigator Name
Maria Gold
Principal Investigator Email
maria.gold@stpoelten.lknoe.at
Contact Person Name
Maria Gold
Contact Person Email
maria.gold@stpoelten.lknoe.at

France

Earliest CTIS Part Ii Submission Date
02-09-2025
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
45
Number Of Sites
11
Number Of Participants
24

Sites

Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Oncology
Principal Investigator Name
Sylvain Ladoire
Principal Investigator Email
sladoire@cgfl.fr
Contact Person Name
Sylvain Ladoire
Contact Person Email
sladoire@cgfl.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Oncology
Principal Investigator Name
Marie Alexandre
Principal Investigator Email
marie.alexandre@icm.unicancer.fr
Contact Person Name
Marie Alexandre
Site Name
Institut Bergonie
Department Name
Oncology
Principal Investigator Name
Celine Blaye
Principal Investigator Email
c.blaye@bordeaux.unicancer.fr
Contact Person Name
Celine Blaye
Contact Person Email
c.blaye@bordeaux.unicancer.fr
Site Name
Institut Paoli Calmettes
Department Name
Oncology
Principal Investigator Name
Alexandre Tassin de Nonneville
Principal Investigator Email
denonnevillea@ipc.unicancer.fr
Contact Person Name
Alexandre Tassin de Nonneville
Contact Person Email
denonnevillea@ipc.unicancer.fr
Site Name
Centre Oscar Lambret
Department Name
Oncology
Principal Investigator Name
Nawale Hajjaji
Principal Investigator Email
n-hajjaji@o-lambret.fr
Contact Person Name
Nawale Hajjaji
Contact Person Email
n-hajjaji@o-lambret.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncology
Principal Investigator Name
Mario Campone
Principal Investigator Email
mario.campone@ico.unicancer.fr
Contact Person Name
Mario Campone
Contact Person Email
mario.campone@ico.unicancer.fr
Site Name
Centre Jean Perrin
Department Name
Oncology
Principal Investigator Name
Marie-Ange Mouret-Reynier
Contact Person Name
Marie-Ange Mouret-Reynier
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncology
Principal Investigator Name
Perrine Vuagnat
Principal Investigator Email
p.vuagnat@rennes.unicancer.fr
Contact Person Name
Perrine Vuagnat
Contact Person Email
p.vuagnat@rennes.unicancer.fr
Site Name
Oncopole Claudius Regaud
Department Name
Oncology
Principal Investigator Name
Florence Dalenc
Principal Investigator Email
dalenc.florence@iuct-oncopole.fr
Contact Person Name
Florence Dalenc
Site Name
Centre Leon Berard
Department Name
Oncology
Principal Investigator Name
Olivier Tredan
Principal Investigator Email
olivier.tredan@lyon.unicancer.fr
Contact Person Name
Olivier Tredan
Site Name
Institut Gustave Roussy
Department Name
Oncology
Principal Investigator Name
Thomas Grinda
Principal Investigator Email
thomas.grinda@gustaveroussy.fr
Contact Person Name
Thomas Grinda
Contact Person Email
thomas.grinda@gustaveroussy.fr

Germany

Earliest CTIS Part Ii Submission Date
14-10-2025
Latest Decision Or Authorization Date
22-10-2025
Processing Time Days
8
Number Of Sites
15
Number Of Participants
25

Sites

Site Name
Gynaekologisches Zentrum Bonn
Department Name
Studien
Principal Investigator Name
Christian Kurbacher
Principal Investigator Email
studie-c.kurbacher@praxis-kurbacher.de
Contact Person Name
Christian Kurbacher
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinik für Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Christian Scholz
Principal Investigator Email
christian.scholz@vivantes.de
Contact Person Name
Christian Scholz
Contact Person Email
christian.scholz@vivantes.de
Site Name
Universitaetsklinikum Augsburg
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Nina Ditsch
Principal Investigator Email
nina.ditsch@uk-augsburg.de
Contact Person Name
Nina Ditsch
Contact Person Email
nina.ditsch@uk-augsburg.de
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Theresa Link
Principal Investigator Email
theresa.link@ukdd.de
Contact Person Name
Theresa Link
Contact Person Email
theresa.link@ukdd.de
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik für Frauenheilkunde / Brustzentrum
Principal Investigator Name
Jennifer Spönlein
Principal Investigator Email
j.spoenlein@kem-med.com
Contact Person Name
Jennifer Spönlein
Contact Person Email
j.spoenlein@kem-med.com
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe (Gynäkologie)
Principal Investigator Name
Maggie Banys-Paluchowski
Principal Investigator Email
maggie.banys-paluchowski@uksh.de
Contact Person Name
Maggie Banys-Paluchowski
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Sabine Heublein
Principal Investigator Email
sabine.heublein@uniklinik-ulm.de
Contact Person Name
Sabine Heublein
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Gynäkologie mit Brustzentrum
Principal Investigator Name
Caroline Neeb
Principal Investigator Email
caroline.neeb@charite.de
Contact Person Name
Caroline Neeb
Contact Person Email
caroline.neeb@charite.de
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
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
Goethe University Frankfurt
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Christine Solbach
Principal Investigator Email
solbach@med.uni-frankfurt.de
Contact Person Name
Christine Solbach
Contact Person Email
solbach@med.uni-frankfurt.de
Site Name
Rotkreuzklinikum Muenchen gGmbH
Department Name
Frauenklinik
Principal Investigator Name
Michael Braun
Principal Investigator Email
michael.braun@swmbrk.de
Contact Person Name
Michael Braun
Contact Person Email
michael.braun@swmbrk.de
Site Name
Gemeinschaftspraxis Fuer Haematologie Und Onkologie
Department Name
Hämatologie und Onkologie
Principal Investigator Name
Andreas Köhler
Principal Investigator Email
dr.koehler@onkologie-langen.de
Contact Person Name
Andreas Köhler
Contact Person Email
dr.koehler@onkologie-langen.de
Site Name
Klinikum Esslingen GmbH
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Alexander Hein
Principal Investigator Email
a.hein.cto@klinikum-esslingen.de
Contact Person Name
Alexander Hein
Site Name
Luisenkrankenhaus GmbH & Co. KG
Department Name
Studien
Principal Investigator Name
Athina Kostara
Principal Investigator Email
athina.kostara@gynonco.de
Contact Person Name
Athina Kostara
Contact Person Email
athina.kostara@gynonco.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Sektion Gynäkologische Onkologie
Principal Investigator Name
Carlo Fremd
Principal Investigator Email
carlo.fremd@med.uni-heidelberg.de
Contact Person Name
Carlo Fremd

Greece

Earliest CTIS Part Ii Submission Date
17-07-2025
Latest Decision Or Authorization Date
20-10-2025
Processing Time Days
95
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
University General Hospital Of Heraklion
Department Name
Department of Medical Oncology
Principal Investigator Name
Dimitrios Mavroudis
Principal Investigator Email
medoncsec@med.uoc.gr
Contact Person Name
Dimitrios Mavroudis
Contact Person Email
medoncsec@med.uoc.gr
Site Name
Saint Savvas Oncology Hospital
Department Name
2nd Department of Medical Oncology
Principal Investigator Name
Dimitrios Tryfonopoulos
Principal Investigator Email
tryfonopoulos@hotmail.com
Contact Person Name
Dimitrios Tryfonopoulos
Contact Person Email
tryfonopoulos@hotmail.com
Site Name
Metropolitan Hospital
Department Name
2nd Oncology Department
Principal Investigator Name
Christos Christodoulou
Principal Investigator Email
c.christodoulou_trials@yahoo.gr
Contact Person Name
Christos Christodoulou

Italy

Earliest CTIS Part Ii Submission Date
17-07-2025
Latest Decision Or Authorization Date
22-10-2025
Processing Time Days
97
Number Of Sites
11
Number Of Participants
20

Sites

Site Name
Azienda USL Toscana Centro
Department Name
SOC Oncologia Medica
Principal Investigator Name
Laura Biganzoli
Principal Investigator Email
laura.biganzoli@uslcentro.toscana.it
Contact Person Name
Laura Biganzoli
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
Oncology Unit
Principal Investigator Name
Luigi Coltelli
Principal Investigator Email
luigi.coltelli@uslnordovest.toscana.it
Contact Person Name
Luigi Coltelli
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Division of Oncology
Principal Investigator Name
Alessandra Gennari
Principal Investigator Email
alessandra.gennari@med.uniupo.it
Contact Person Name
Alessandra Gennari
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Clinica di Oncologia Medica
Principal Investigator Name
Lucia Del Mastro
Principal Investigator Email
lucia.delmastro@hsanmartino.it
Contact Person Name
Lucia Del Mastro
Contact Person Email
lucia.delmastro@hsanmartino.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
Principal Investigator Name
Giuseppe Curigliano
Principal Investigator Email
giuseppe.curigliano@ieo.it
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncology 2
Principal Investigator Name
Valentina Guarneri
Principal Investigator Email
valentina.guarneri@unipd.it
Contact Person Name
Valentina Guarneri
Contact Person Email
valentina.guarneri@unipd.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOSD Medicina di precisione in senologia
Principal Investigator Name
Alessandra Fabi
Principal Investigator Email
alessandra.fabi@policlinicogemelli.it
Contact Person Name
Alessandra Fabi
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Oncologia Medica
Principal Investigator Name
Fabio Puglisi
Principal Investigator Email
fabio.puglisi@cro.it
Contact Person Name
Fabio Puglisi
Contact Person Email
fabio.puglisi@cro.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Medical oncology unit
Principal Investigator Name
Claudio Zamagni
Principal Investigator Email
claudio.zamagni@aosp.bo.it
Contact Person Name
Claudio Zamagni
Contact Person Email
claudio.zamagni@aosp.bo.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Clinical Medicine and Surgery
Principal Investigator Name
Grazia Arpino
Principal Investigator Email
grazia.arpino@unina.it
Contact Person Name
Grazia Arpino
Contact Person Email
grazia.arpino@unina.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Breast oncology division
Principal Investigator Name
Michelino De Laurentiis
Principal Investigator Email
m.delaurentiis@istitutotumori.na.it
Contact Person Name
Michelino De Laurentiis

Romania

Earliest CTIS Part Ii Submission Date
29-09-2025
Latest Decision Or Authorization Date
22-10-2025
Processing Time Days
23
Number Of Sites
11
Number Of Participants
20

Sites

Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncology
Principal Investigator Name
Nicoleta Antone
Principal Investigator Email
office@iocn.ro
Contact Person Name
Nicoleta Antone
Contact Person Email
office@iocn.ro
Site Name
Spitalul Clinic Filantropia
Department Name
Oncology
Principal Investigator Name
Mircea Dragos Median
Principal Investigator Email
dragos.median@gmail.com
Contact Person Name
Mircea Dragos Median
Contact Person Email
dragos.median@gmail.com
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncology
Principal Investigator Name
Alexandru Ungureanu
Principal Investigator Email
office.cluj@amethyst-radiotherapy.ro
Contact Person Name
Alexandru Ungureanu
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncology
Principal Investigator Name
Michael Schenker
Principal Investigator Email
office@centruldeoncologie.ro
Contact Person Name
Michael Schenker
Contact Person Email
office@centruldeoncologie.ro
Site Name
Centrul de Radioterapie Amethyst Timis
Department Name
Oncology
Principal Investigator Name
Loredana Elena Boscuta
Principal Investigator Email
boscuta.lore@gmail.com
Contact Person Name
Loredana Elena Boscuta
Contact Person Email
boscuta.lore@gmail.com
Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Oncology
Principal Investigator Name
Simona Volovat
Principal Investigator Email
simonavolovat@gmail.com
Contact Person Name
Simona Volovat
Contact Person Email
simonavolovat@gmail.com
Site Name
Oncomed S.R.L.
Department Name
Oncology
Principal Investigator Name
Cristina Oprean
Principal Investigator Email
coprean@yahoo.com
Contact Person Name
Cristina Oprean
Contact Person Email
coprean@yahoo.com
Site Name
Institutul Regional De Oncologie Iasi
Department Name
Oncology
Principal Investigator Name
Eva Maria Cojocaru
Principal Investigator Email
manager@iroiasi.ro
Contact Person Name
Eva Maria Cojocaru
Contact Person Email
manager@iroiasi.ro
Site Name
Spitalul Municipal Ploiesti
Department Name
Oncology
Principal Investigator Name
Pompilia Motatu
Principal Investigator Email
pompiliamotatu@yahoo.com
Contact Person Name
Pompilia Motatu
Contact Person Email
pompiliamotatu@yahoo.com
Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Oncology
Principal Investigator Name
Simona Volovat
Principal Investigator Email
simonavolovat@gmail.com
Contact Person Name
Simona Volovat
Contact Person Email
simonavolovat@gmail.com
Site Name
Lotus Med S.R.L.
Department Name
Oncology
Principal Investigator Name
Iuliana Pantelimon
Principal Investigator Email
pantelimon.iuliana@gmail.com
Contact Person Name
Iuliana Pantelimon
Contact Person Email
pantelimon.iuliana@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
23-09-2025
Latest Decision Or Authorization Date
20-10-2025
Processing Time Days
27
Number Of Sites
12
Number Of Participants
24

Sites

Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
ONCOLOGY
Principal Investigator Name
Silvia Antolin
Principal Investigator Email
silvia.antolin.novoa@sergas.es
Contact Person Name
Silvia Antolin
Contact Person Email
silvia.antolin.novoa@sergas.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
MEDICAL ONCOLOGY
Principal Investigator Name
Sara Lopez Tarruella
Principal Investigator Email
xxxx@xxxx.xx
Contact Person Name
Sara Lopez Tarruella
Contact Person Email
xxxx@xxxx.xx
Site Name
Hospital Beata Maria Ana
Department Name
ONCOLOGY
Principal Investigator Name
Javier Cortes
Principal Investigator Email
javier.cortes@maj3.health
Contact Person Name
Javier Cortes
Contact Person Email
javier.cortes@maj3.health
Site Name
Hospital Universitario Donostia
Department Name
ONCOLOGY
Principal Investigator Name
Isabel Alvarez
Principal Investigator Email
isabelmanuela.alvarezlopez@osakidetza.eus
Contact Person Name
Isabel Alvarez
Site Name
Hospital Universitari Vall D Hebron
Department Name
ONCOLOGY
Principal Investigator Name
Ana Mafalda Antunes de Melo e Oliveira
Principal Investigator Email
moliveira@vhio.net
Contact Person Name
Ana Mafalda Antunes de Melo e Oliveira
Contact Person Email
moliveira@vhio.net
Site Name
Hospital Clinico Universitario De Valencia
Department Name
ONCOLOGY
Principal Investigator Name
Begoña Bermejo
Principal Investigator Email
xxxx@xxx.com
Contact Person Name
Begoña Bermejo
Contact Person Email
xxxx@xxx.com
Site Name
Hospital General Universitario De Elche
Department Name
MEDICAL ONCOLOGY
Principal Investigator Name
Alvaro Rodriguez-Lescure
Principal Investigator Email
alescure@geicam.org
Contact Person Name
Alvaro Rodriguez-Lescure
Contact Person Email
alescure@geicam.org
Site Name
Hospital Clinic De Barcelona
Department Name
ONCOLOGY
Principal Investigator Name
Marta Gonzalez
Principal Investigator Email
gonzalez20@recerca.clinic.cat
Contact Person Name
Marta Gonzalez
Contact Person Email
gonzalez20@recerca.clinic.cat
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
ONCOLOGY
Principal Investigator Name
Luis de la Cruz Merino
Principal Investigator Email
xxxxxxx@xxx.xx
Contact Person Name
Luis de la Cruz Merino
Contact Person Email
xxxxxxx@xxx.xx
Site Name
Hospital Universitario 12 De Octubre
Department Name
ONCOLOGY
Principal Investigator Name
Eva Maria Ciruelos
Principal Investigator Email
xxxx@xxx.com
Contact Person Name
Eva Maria Ciruelos
Contact Person Email
xxxx@xxx.com
Site Name
Institut Catala D'oncologia
Department Name
ONCOLOGY
Principal Investigator Name
Agostina Stradella
Principal Investigator Email
astradella@iconcologia.net
Contact Person Name
Agostina Stradella
Contact Person Email
astradella@iconcologia.net
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
ONCOLOGY
Principal Investigator Name
Maria Emilia Dominguez Recio
Principal Investigator Email
xxxx@xxxx.xx
Contact Person Name
Maria Emilia Dominguez Recio
Contact Person Email
xxxx@xxxx.xx

Sweden

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
20-10-2025
Processing Time Days
31
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Uppsala University Hospital
Department Name
VO Blod- och tumörsjukdomar, Sektionen för onkologi
Principal Investigator Name
Henrik Lindman
Principal Investigator Email
henrik.lindman@akademiska.se
Contact Person Name
Henrik Lindman
Contact Person Email
henrik.lindman@akademiska.se
Site Name
Region Oerebro Laen
Department Name
Universitetssjukhuset Örebro Onkologiska kliniken
Principal Investigator Name
Antonis Valachis
Principal Investigator Email
antonios.valachis@oru.se
Contact Person Name
Antonis Valachis
Contact Person Email
antonios.valachis@oru.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Kliniska forskningsenheten, KFE VO Hematologi, onkologi och strålningsfysik
Principal Investigator Name
Ulrik Narbe
Principal Investigator Email
ulrik.narbe@skane.se
Contact Person Name
Ulrik Narbe
Contact Person Email
ulrik.narbe@skane.se
Site Name
Region Oestergoetland
Department Name
Universitetssjukhuset i Linköping, Onkologiska kliniken
Principal Investigator Name
Ahmed Albu-Kareem
Principal Investigator Email
Ahmed.Albu-Kareem@regionostergotland.se
Contact Person Name
Ahmed Albu-Kareem
Site Name
Capio S:t Goerans Sjukhus AB
Department Name
Capio S:t Görans sjukhus, Bröstcentrum onkologi
Principal Investigator Name
Luisa Edman Kessler
Principal Investigator Email
luisa.edmankessler@capiostgoran.se
Contact Person Name
Luisa Edman Kessler

Poland

Earliest CTIS Part Ii Submission Date
26-09-2025
Latest Decision Or Authorization Date
26-10-2025
Processing Time Days
30
Number Of Sites
7
Number Of Participants
11

Sites

Site Name
Aidport Sp. z o.o.
Principal Investigator Name
Renata Szoszkiewicz
Principal Investigator Email
joanna.lorenc@aidport.pl
Contact Person Name
Renata Szoszkiewicz
Contact Person Email
joanna.lorenc@aidport.pl
Site Name
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Department Name
Ośrodek Innowacyjnych Terapii
Principal Investigator Name
Maria Pawlowicz
Principal Investigator Email
sekretariat@szpitalbp.pl
Contact Person Name
Maria Pawlowicz
Contact Person Email
sekretariat@szpitalbp.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej
Principal Investigator Name
Zbigniew Nowecki
Principal Investigator Email
nowotworypiersi@pib-nio.pl
Contact Person Name
Zbigniew Nowecki
Contact Person Email
nowotworypiersi@pib-nio.pl
Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Klinika Onkologii
Principal Investigator Name
Ewa Kalinka
Principal Investigator Email
sek.onkol.kl@iczmp.edu.pl
Contact Person Name
Ewa Kalinka
Contact Person Email
sek.onkol.kl@iczmp.edu.pl
Site Name
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Department Name
Mazowiecki Szpital Onkologiczny, Poradnia Onkologiczna/Al. Solidarności 10
Principal Investigator Name
Michal Kunkiel
Principal Investigator Email
sekretariat@szpitalonkologiczny.pl
Contact Person Name
Michal Kunkiel
Site Name
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Klinika Onkologii z Odcinkiem Dziennym
Principal Investigator Name
Barbara Radecka
Principal Investigator Email
kliniczna@onkologia.opole.pl
Contact Person Name
Barbara Radecka
Contact Person Email
kliniczna@onkologia.opole.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (additional site entries exist)

Portugal

Earliest CTIS Part Ii Submission Date
07-10-2025
Latest Decision Or Authorization Date
20-10-2025
Processing Time Days
13
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Department Name
Medical Oncology
Principal Investigator Name
Gabriela Sousa
Principal Investigator Email
gsousa@ipocoimbra.min-saude.pt
Contact Person Name
Gabriela Sousa
Contact Person Email
gsousa@ipocoimbra.min-saude.pt
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Medical Oncology
Principal Investigator Name
Isabel Augusto
Principal Investigator Email
centro.investigacao@chsj.min-saude.pt
Contact Person Name
Isabel Augusto
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Medical Oncology
Principal Investigator Name
Sara Magno
Principal Investigator Email
smagno@ipolisboa.min-saude.pt
Contact Person Name
Sara Magno
Contact Person Email
smagno@ipolisboa.min-saude.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Medical Oncology
Principal Investigator Name
Luís Costa
Principal Investigator Email
xxxxxxx@xxxx.com
Contact Person Name
Luís Costa
Contact Person Email
xxxxxxx@xxxx.com
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Medical Oncology
Principal Investigator Name
Ana Afonso
Principal Investigator Email
ana.freitas.afonso@ipoporto.min-saude.pt
Contact Person Name
Ana Afonso
Site Name
Hospital Da Luz S.A.
Department Name
Medical Oncology
Principal Investigator Name
Catarina Pulido
Principal Investigator Email
catarina.pulido@hospitaldaluz.pt
Contact Person Name
Catarina Pulido

Sponsor

Primary sponsor

Full Name
Bristol-Myers Squibb Services Unlimited Company
Organisation Type
Pharmaceutical company
Country Of Registered Address
Ireland

Contract research organisations

Name
Clario
Responsibilities
Medical image analysis/ review - X-ray, MRI, ultrasound, etc; Customer Care / Site Logistics / Training / Equipment Customization
Name
Pharmaceutical Product Development LLC
Responsibilities
Bioanalytical analysis
Name
Signant Health Global LLC
Responsibilities
PRO/COA

Third parties

  • {"country":"United States","full_name":"Clario","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc; Customer Care / Site Logistics / Training / Equipment Customization","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"PRO/COA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Bioanalytical analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements, electronic study-related communications to patients","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Tumor blocks/slides storage, PGX spl, spl storage for vendors, IHC, Legacy LabCorp Central Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data Management Platform","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
BL-B01D1
Active Substance
IZALONTAMAB BRENGITECAN
Modality
ADC
Routes Of Administration
INTRAVENUS USE
Route
INTRAVENUS USE
Investigational Product Name
GEMCITABINE
Active Substance
GEMCITABINE
Modality
Small molecule
Routes Of Administration
INTRAVENUS USE
Route
INTRAVENUS USE
Maximum Dose
2500 mg/m2 (maxDailyDoseAmount as recorded)
Investigational Product Name
PEGFILGRASTIM
Active Substance
PEGFILGRASTIM
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Maximum Dose
6 mg (maxDailyDoseAmount as recorded)
Investigational Product Name
PACLITAXEL ALBUMIN-BOUND
Active Substance
PACLITAXEL ALBUMIN-BOUND
Modality
Small molecule
Routes Of Administration
INTRAVENUS USE
Route
INTRAVENUS USE
Maximum Dose
250 mg/m2 (maxDailyDoseAmount as recorded)
Investigational Product Name
CAPECITABINE
Active Substance
CAPECITABINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Maximum Dose
6250 mg/m2 (maxDailyDoseAmount as recorded)
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENUS USE
Route
INTRAVENUS USE
Maximum Dose
300 mg/ml (maxDailyDoseAmount as recorded)
Investigational Product Name
PACLITAXEL
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENUS USE
Route
INTRAVENUS USE
Maximum Dose
225 mg/m2 (maxDailyDoseAmount as recorded)
Combination Treatment
Yes

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