Clinical trial • Phase III • Oncology

BNT327 for Triple-negative breast cancer (TNBC)

Phase III trial of BNT327 for Triple-negative breast cancer (TNBC).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Triple-negative breast cancer (TNBC)
Trial Stage
Phase III
Drug Modality
Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
24-10-2025
First CTIS Authorization Date
04-03-2026

Trial design

Randomised, placebo (bnt327 placebo) plus chemotherapy (investigator choice of chemotherapy: paclitaxel — dose unit mg/m2, maxdailydoseamount 3.8 mg/m2; abraxane (paclitaxel albumin-bound) — dose unit mg/m2, maxdailydoseamount 3.57 mg/m2; gemcitabine (gemcitabine hydrochloride) — dose unit mg/m2, maxdailydoseamount 47.62 mg/m2; carboplatin (carboplatin) — doseuom other, maxdailydoseamount 10.5; eribulin (eribulin mesylate) — dose unit mg/m2, maxdailydoseamount 0.06). specific schedules not detailed in the ctis record.-controlled Phase III trial in Belgium, Czechia, Germany and others.

Randomised
Yes
Comparator
Placebo (BNT327 Placebo) plus chemotherapy (investigator choice of chemotherapy: PACLITAXEL — dose unit mg/m2, maxDailyDoseAmount 3.8 mg/m2; Abraxane (paclitaxel albumin-bound) — dose unit mg/m2, maxDailyDoseAmount 3.57 mg/m2; GEMCITABINE (gemcitabine hydrochloride) — dose unit mg/m2, maxDailyDoseAmount 47.62 mg/m2; CARBOPLATIN (carboplatin) — doseUom Other, maxDailyDoseAmount 10.5; ERIBULIN (eribulin mesylate) — dose unit mg/m2, maxDailyDoseAmount 0.06). Specific schedules not detailed in the CTIS record.
Target Sample Size
414

Eligibility

Recruits 414 Exclusion criterion: "Are a vulnerable individual, i.e., an individual whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate." Consent requirement: "Are able to give informed consent and have given written consent in accordance with ICH GCP and local legislation prior to the start of any trial-specific procedures.".

Pregnancy Exclusion
Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.
Vulnerable Population
Exclusion criterion: "Are a vulnerable individual, i.e., an individual whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate." Consent requirement: "Are able to give informed consent and have given written consent in accordance with ICH GCP and local legislation prior to the start of any trial-specific procedures."

Inclusion criteria

  • {"criterion_text":"- Adults, of 18 years of age or older at the time of giving informed consent. Local laws will be followed if the age of consent is older.\n- Are men who are sterile or if they are potentially fertile and sexually active with a partner of childbearing potential, who agree to use condoms and to ask their sexual partners to practice a highly effective form of contraception during the trial, starting from the time of giving informed consent and continuously until 6 months after receiving the last dose of pumitamig or placebo.\n- Agree not to donate and/or cryopreserve germ cells (sperm, oocytes, ova) for the purposes of assisted reproduction during trial, from signing the informed consent form and continuously until 6 months after the last dose of pumitamig or placebo.\n- Are able to give informed consent and have given written consent in accordance with ICH GCP and local legislation prior to the start of any trial-specific procedures.\n- Are willing and able to comply with scheduled visits, the treatment schedule, the planned trial assessments (including patient completed diaries) and other requirements of the trial. This includes that they are able to understand and follow trial-related instructions.\n- Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.\n- Have confirmed locally recurrent inoperable or metastatic TNBC, or ER-low, HER2-negative breast cancer documented prior to trial screening as part of standard of care and whose disease status aligns the detailed description in the protocol.\n- Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.\n- Have provided a tissue sample, archival or fresh, during the screening period.\n- ECOG performance status (PS) of 0 or 1.\n- Have adequate organ function in regards to haematology, liver function, kidney function, and coagulation.\n- Are people of child-bearing potential (POCBP) who have a negative serum beta hCG pregnancy test within 7 days of the start of trial treatment.\n- Are POCBP who agree to practice a highly effective form of contraception and to require their male sexual partners to use barrier contraception methods (preferably condoms), starting at the time of giving informed consent and continuously until 6 months after receiving the last dose of pumitamig or placebo."}

Exclusion criteria

  • {"criterion_text":"- Have received any of the following therapies or drugs prior to the initiation of trial: • prior systemic anticancer therapy for advanced disease. • prior treatment with a PD(L)-1/VEGF bispecific antibody. • systemic corticosteroids within 7 days prior to the initiation of trial treatment. • Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment. • Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment.\n- Have a history of hepatitis B requiring active antiviral therapy.\n- Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the trial, or that could prevent, limit, or confound the protocol-specified assessments or procedures, or that could impact adherence to protocol described requirements.\n- Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.\n- Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial.\n- Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.\n- Have spinal cord compression or central nervous system metastases that are untreated and symptomatic or require treatment with corticosteroids or anticonvulsants for associated-symptom control.\n- Have active autoimmune disease that has required systemic treatment in the past 2 years\n- Have had other malignant tumors within 2 years prior to the trial treatment.\n- Have any heart conditions within 6 months prior to the trial treatment as described in the study protocol.\n- Have an active hepatitis C virus infection.\n- Have hypertension or diabetic conditions prior to initiation of trial treatment as defined in the study protocol.\n- Are a vulnerable individual, i.e., an individual whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.\n- Have superior vena cava syndrome or symptoms of spinal cord compression.\n- Have active, or a history of, pneumonitis requiring treatment with steroids, or active, or a history of, interstitial lung disease.\n- Have a history of tuberculosis that was not successfully treated.\n- Have serious non-healing wounds, ulcers, or bone fractures.\n- Have evidence of major coagulation disorders or other significant risks of hemorrhage as defined in the study protocol.\n- Receive therapeutic anticoagulation or antiplatelet therapy.\n- Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.\n- Have a history of serious Grade 3 or higher irAEs that led to treatment discontinuation of a prior immunotherapy or have AEs from prior antitumor therapy that have not returned to Grade 1\n- Have a known or suspected hypersensitivity to the trial treatments including any active ingredient or excipients thereof.\n- Have a known history of human immunodeficiency virus with CD4+ T˗cell counts below 350 cells/µL and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival (OS) defined as the time from randomization to death from any cause.","definition_or_measurement_approach":"OS defined as the time from randomization to death from any cause (time-to-event)."}
  • {"endpoint_text":"- Progression-free survival (PFS) defined as the time from randomization to first documented tumor progression (assessed by blinded independent central review (BICR) per RECIST v1.1), or death from any cause, whichever occurs first.","definition_or_measurement_approach":"PFS measured as time from randomization to first documented tumor progression assessed by blinded independent central review (BICR) per RECIST v1.1, or death from any cause."}

Secondary endpoints

  • {"endpoint_text":"- Objective response rate (ORR) defined as the proportion of patients in whom a confirmed complete response (CR) or confirmed partial response (PR) (per RECIST v1.1) is assessed by BICR as best overall response.","definition_or_measurement_approach":"Proportion of patients with confirmed CR or PR per RECIST v1.1 assessed by BICR."}
  • {"endpoint_text":"- PFS defined as the time from randomization to first documented tumor progression (assessed by investigator per RECIST v1.1), or death from any cause, whichever occurs first.","definition_or_measurement_approach":"Investigator-assessed PFS per RECIST v1.1 (time-to-event)."}
  • {"endpoint_text":"- Objective response rate (ORR) defined as the proportion of patients in whom a confirmed complete response (CR) or confirmed partial response (PR) (per RECIST v1.1) is observed as best overall response.","definition_or_measurement_approach":"Proportion of patients with confirmed CR or PR per RECIST v1.1 (investigator assessment as stated in secondary endpoint text)."}
  • {"endpoint_text":"- Duration of response (DOR) defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first","definition_or_measurement_approach":"Time from first objective response (CR or PR per RECIST v1.1) to objective tumor progression or death."}
  • {"endpoint_text":"- Disease control rate (DCR) defined as the proportion of patients in whom a confirmed CR or confirmed PR or SD (per RECIST v1.1, SD assessed at least 6 weeks after randomization) is observed as best overall response.","definition_or_measurement_approach":"Proportion of patients with confirmed CR, PR or SD (SD assessed ≥6 weeks after randomization) per RECIST v1.1."}
  • {"endpoint_text":"- Progression-free survival (PFS) rate as assessed by BICR at 6, 12, 18, and 24 months.","definition_or_measurement_approach":"PFS rate (BICR) at specified timepoints (6, 12, 18, 24 months)."}
  • {"endpoint_text":"- Progression-free survival (PFS) rate as assessed by investigator at 6, 12, 18, and 24 months.","definition_or_measurement_approach":"Investigator-assessed PFS rate at specified timepoints (6, 12, 18, 24 months)."}
  • {"endpoint_text":"- Overall survival (OS) rate at 6, 12, 18, and 24 months.","definition_or_measurement_approach":"OS rate at specified timepoints (6, 12, 18, 24 months)."}
  • {"endpoint_text":"- Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥3 according to NCI CTCAE v5.0, serious, and fatal TEAEs by relationship, from the first dose of pumitamig or placebo to 90 days after last dose of trial treatment.","definition_or_measurement_approach":"Safety assessment: incidence and severity (NCI CTCAE v5.0) of TEAEs from first dose to 90 days post last dose."}
  • {"endpoint_text":"- Occurrence of dose interruption, reduction, and discontinuation of trial treatment due to TEAEs (including related TEAEs) from the first dose of pumitamig or placebo to 90 days after last dose of trial treatment.","definition_or_measurement_approach":"Assessment of dose modifications and treatment discontinuations due to TEAEs from first dose to 90 days post last dose."}
  • {"endpoint_text":"- Change from baseline in EORTC Quality of Life (QLQ)-C30 Global Health status / Quality-of-Life score (Items 29 and 30).","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 global health/QoL (items 29 & 30)."}
  • {"endpoint_text":"- Change from baseline in EORTC QLQ-C30 physical functioning.","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 physical functioning domain."}
  • {"endpoint_text":"- Change from baseline in arm symptoms scale of the EORTC QLQ-BR42.","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-BR42 arm symptoms scale."}
  • {"endpoint_text":"- Change from baseline in breast symptoms scale of the EORTC QLQ-BR42.","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-BR42 breast symptoms scale."}
  • {"endpoint_text":"- Change from baseline in the Functional Assessment of Cancer Therapy - General (FACT-G) overall bother item (FACT-GP5).","definition_or_measurement_approach":"Change from baseline in FACT-G overall bother item (FACT-GP5)."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
414
Recruitment Window Months
49
Consent Approach
Written informed consent must be provided by the participant prior to any trial-specific procedures in accordance with ICH GCP and local legislation; participants must be adults (18 years or older; local laws followed if age for consent is higher). Subject information and ICF materials are available in multiple languages (documents in English, Dutch, French, German, Italian, Spanish, Polish, Czech are present in the submission). Pregnancy-specific ICFs and partner forms are included. No pediatric assent is applicable because the study includes adults only.

Methods

  • Use of printed recruitment materials at sites: posters, flyers, brochures and 1- and 2-page flyers (materials available in multiple languages).
  • Online/digital postings: 'K2_Online Postings' and other online recruitment materials for multiple languages (English, Dutch, French, etc.).
  • Patient-facing letters and patient brochures sent/available via sites ('K2_Patient Letter', 'K2_Brochure').
  • ICF flipbook and subject information documents provided at site (subject information/informed consent forms in multiple languages).
  • Site-based recruitment: site selection and patient recruitment activities provided by third parties (e.g. Paradigm Health Inc. noted for site selection and patient recruitment in US and Japan; GBG Forschungs GmbH noted for patient recruitment and retention support).
  • Advocacy-facing materials: 'K2_Advocacy Factsheet' used to inform advocacy stakeholders (language-specific versions available).

Geography

Total Number Of Sites
61
Total Number Of Participants
119

Belgium

Earliest CTIS Part Ii Submission Date
04-02-2026
Latest Decision Or Authorization Date
04-03-2026
Processing Time Days
28
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Centre hospitalier universitaire de Liege
Department Name
Medical Oncology
Contact Person Name
Andrée Rorive
Contact Person Email
Andree.rorive@chuliege.be
Site Name
UZ Leuven
Department Name
Medical Oncology
Contact Person Name
Hans Wildiers
Contact Person Email
Hans.wildiers@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Contact Person Name
François Duhoux
Contact Person Email
Fancois.duhoux@uclouvain.be
Site Name
Imelda
Department Name
Oncology & Hematology
Contact Person Name
Wim Wynendaele
Contact Person Email
Wim.wynendaele@imelda.be
Site Name
UZ Brussel
Department Name
Medical Oncology
Contact Person Name
Christel Fontaine
Contact Person Email
Christel.fontaine@uzbrussel.be
Site Name
Grand Hopital De Charleroi
Department Name
Oncology & Hematology
Contact Person Name
Sarah Lefevre
Contact Person Email
Sarah.lefevre@ghdc.be

Czechia

Earliest CTIS Part Ii Submission Date
04-02-2026
Latest Decision Or Authorization Date
04-03-2026
Processing Time Days
28
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
Pracoviště MOTOL, Onkologická klinika 2. LF Ua FN Motol
Contact Person Name
Tomáš Büchler
Contact Person Email
tomas.buchler@fnmool.cz
Site Name
Multiscan s.r.o.
Department Name
Onkologický stacionář
Contact Person Name
Martin Šmakal
Contact Person Email
liskova@multiscan.cz
Site Name
Multiscan s.r.o.
Department Name
Oddělení klinické a radiační onkologie
Contact Person Name
Karel Odrážka
Contact Person Email
odrazka@multiscan.cz
Site Name
Fakultni Thomayerova nemocnice
Department Name
Onkologická klinika 1. LF UK a FTN
Contact Person Name
Eugen Kubala
Contact Person Email
eugen.kubala@ftn.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Oddělení radioterapie a onkologie
Contact Person Name
Magdalena Halámka
Contact Person Email
magdalena.halamka@nnj.agel.cz

Germany

Earliest CTIS Part Ii Submission Date
16-02-2026
Latest Decision Or Authorization Date
04-03-2026
Processing Time Days
16
Number Of Sites
14
Number Of Participants
28

Sites

Site Name
Hamatologische Onkologische Praxis Im Medicum
Contact Person Name
Carsten Schreiber
Site Name
Technische Universitaet Dresden
Department Name
Gynäkologisches Krebszentrum und Regionales Brustzentrum
Contact Person Name
Theresa Link
Site Name
Heidelberg University
Department Name
Frauenklinik
Contact Person Name
Frederik Marmé
Contact Person Email
Frederik.marme@umm.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Gynäkologie und Frauenheilkunde
Contact Person Name
Marcus Schmidt
Site Name
Haematologie-Onkologie im Zentrum MVZ GmbH
Contact Person Name
Bernhard Heinrich
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik für Senologie / Brustzentrum
Contact Person Name
Sherko Kuemmel
Contact Person Email
s.kuemmel@kem-med.com
Site Name
Mammazentrum Hamburg MVZ GbR
Contact Person Name
Christian Schem
Contact Person Email
schem@mammazentrum.eu
Site Name
Franziskus Hospital Harderberg
Department Name
Zentrum für internistische Hämatologie und Onkologie
Contact Person Name
Kerstin Luedtke-Heckenkamp
Site Name
Goethe University Frankfurt
Department Name
Hematology/Oncology
Contact Person Name
Sibylle Loibl
Site Name
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
Contact Person Name
Matthias Zaiss
Site Name
Klinikum Nuernberg
Department Name
Klinik für Innere Medizin 5, Schwerpunkte Onkologie und Hämatologie
Contact Person Name
Stefan Knop
Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
Brustzentrum Ostthüringen
Contact Person Name
Dirk-Michael Zahm
Contact Person Email
zahm.studienzentrum.wkg@srh.de
Site Name
Institut Fuer Versorgungsforschung In Der Onkologie GbR
Department Name
Praxisklinik für Hämatologie und Onkologie
Contact Person Name
Rudolf Weide
Contact Person Email
weide@invo-koblenz.de
Site Name
Klinikum Worms gGmbH
Department Name
Frauenklinik
Contact Person Name
Matthias Kögel

Italy

Earliest CTIS Part Ii Submission Date
25-02-2026
Latest Decision Or Authorization Date
04-03-2026
Processing Time Days
7
Number Of Sites
10
Number Of Participants
17

Sites

Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
UOC Oncologia Medica - Ospedale San Luca
Contact Person Name
Edi Editta Baldini
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Research Unit Phase I Trials
Contact Person Name
Marina Elena Cazzaniga
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
SOC Oncologia medica e prevenzione oncologica
Contact Person Name
Fabio Puglisi
Contact Person Email
fabio.puglisi@cro.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Dipartimento di Medicina Interna - SOD Clinica Oncologica
Contact Person Name
Rossana Berardi
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
“Breast Unit” for the UOC of Oncology
Contact Person Name
Francesco Pantano
Contact Person Email
f.pantano@policlinicocampus.it
Site Name
Azienda Ospedaliero-Universitaria Senese
Department Name
U.O.C. Immunoterapia Oncologica
Contact Person Name
Michele Maio
Contact Person Email
maio@unisi.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Dipartimento di S.C. Oncologia Medica 1 – S.S. Oncologia Medica Senologica
Contact Person Name
Giulia Valeria Bianchi
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Senologia Medica
Contact Person Name
Marco Angelo Oscar Colleoni
Contact Person Email
marco.colleoni@ieo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia Medica
Contact Person Name
Giampaolo Bianchini
Contact Person Email
bianchini.giampaolo@hsr.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Oncologia Medica 1
Contact Person Name
Carmelo Bengala

Netherlands

Earliest CTIS Part Ii Submission Date
09-02-2026
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
28
Number Of Sites
5
Number Of Participants
9

Sites

Site Name
Spaarne Gasthuis Stichting
Department Name
Internal Medicine/Oncology
Contact Person Name
Aart Beeker
Contact Person Email
info@spaarnegasthuis.nl
Site Name
Haga Hospital
Department Name
Internal Medicine
Contact Person Name
Danny Houtsma
Contact Person Email
y.visser@hagaziekenhuis.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Medical Oncology
Contact Person Name
Marleen Kok
Contact Person Email
m.kok@nki.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Oncologie
Contact Person Name
Maaike De Boer
Site Name
Ikazia Ziekenhuis
Department Name
Oncology
Contact Person Name
Jan Drooger
Contact Person Email
research-ig@ikazia.nl

Poland

Earliest CTIS Part Ii Submission Date
04-02-2026
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
36
Number Of Sites
8
Number Of Participants
15

Sites

Site Name
Centrum Medyczne Hcp Sp. z o.o.
Department Name
NZOZ Centrum Medyczne HCP Lecznictwo Ambulatoryjne
Contact Person Name
Robert Kobylarek
Contact Person Email
badania.kliniczne@cmhcp.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Klinika Onkologii
Contact Person Name
Rodryg Ramlau
Contact Person Email
katedraonkologii@ump.edu.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Klinika Onkologii
Contact Person Name
Renata Duchnowska
Contact Person Email
rduchnowska@wim.mil.pl
Site Name
Ip Clinic Sp. z o.o.
Department Name
IP CLINIC
Contact Person Name
Małgorzata Ułańska
Contact Person Email
biuro@ipclinic.pl
Site Name
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Klinika Onkologii z Odcinkiem Dziennym
Contact Person Name
Barbara Radecka
Contact Person Email
brad@onkologia.opole.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej
Contact Person Name
Zbigniew Nowecki
Contact Person Email
nowotworypiersi@nio.gov.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Poradnia Onkologiczna oraz Oddział Kliniczny Onkologii
Contact Person Name
Piotr Wysocki
Contact Person Email
piotr.wysocki@uj.edu.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Elżbieta Senkus-Konefka
Contact Person Email
elsenkus@gumed.edu.pl

Spain

Earliest CTIS Part Ii Submission Date
20-02-2026
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
32
Number Of Sites
13
Number Of Participants
26

Sites

Site Name
Parc Tauli Hospital Universitari
Department Name
Servicio de Oncología Médica
Contact Person Name
Luis Fernandez Morales
Contact Person Email
lfernandez@tauli.cat
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Servicio de Oncología Médica
Contact Person Name
Angel Luis Guerrero Zotano
Contact Person Email
aguerrero@fivo.org
Site Name
Hospital Del Mar
Department Name
Servicio de Oncología Médica
Contact Person Name
Maria Martinez Garcia
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Servicio de Oncología Médica
Contact Person Name
Yann Izarzugaza Peron
Contact Person Email
YIzarzugaza@quironsalud.es
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Servicio de Oncología Médica
Contact Person Name
Raquel Bratos Lorenzo
Contact Person Email
rbratos@hmhospitales.com
Site Name
Clinica Universidad De Navarra
Department Name
Servicio de Oncología Médica
Contact Person Name
Marta Santisteban Eslava
Contact Person Email
msantisteb@unav.es
Site Name
Hospital Universitario De Badajoz
Department Name
Servicio de Oncología Médica
Contact Person Name
Juan Ignacio Delgado Mingorance
Site Name
Instituto Oncologico Dr. Rosell S.L.
Department Name
Servicio de Oncología Médica
Contact Person Name
Vanesa Ortega Cebrián
Contact Person Email
vortega@oncorosell.com
Site Name
Hospital General Universitario Morales Meseguer
Department Name
Servicio de Oncología Médica
Contact Person Name
Elisa Isabel Garcia Garre
Contact Person Email
elisaisabel.garcia@um.es
Site Name
Hospital Universitario Reina Sofia
Department Name
Servicio de Oncología Médica
Contact Person Name
Cristina Morales Estevez
Site Name
Clinica Universidad De Navarra (Madrid address)
Department Name
Servicio de Oncología Médica
Contact Person Name
Marta Santisteban Eslava
Contact Person Email
msantisteb@unav.es
Site Name
Hospital Beata Maria Ana
Department Name
Servicio de Oncología Médica
Contact Person Name
Javier Cortes Castan
Contact Person Email
javier.cortes@maj3.health
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Servicio de Oncología Médica
Contact Person Name
Jose Luis Alonso Romero
Contact Person Email
josel.alonso2@carm.es

Sponsor

Primary sponsor

Full Name
BioNTech SE
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Contract Research Organisation

Third parties

  • {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"Sample Analysis: Pharmacokinetics (PK) and Antidrug Antibody (ADA)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Acnos Pharma GmbH","duties_or_roles":"Chemotherapy sourcing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Paradigm Health Inc.","duties_or_roles":"Site selection and Patient Recruitment (US and Japan)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Drug Packaging, Labelling, Distribution, QP Release, Returns and Destruction(excluding China) Third Party Depot Management (excluding China)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Contract Research Organisation","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"GBG Forschungs GmbH","duties_or_roles":"Site selection and start up Patient Recruitment and retention support","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Metronomia Clinical Research GmbH","duties_or_roles":"IDMC unblinded statistician","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Catalent (Shanghai) Clinicl Trial Supplies Co. Ltd.","duties_or_roles":"Drug Packaging, Labelling, Distribution, Returns and Destruction (China only)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Foundation Medicine GmbH","duties_or_roles":"Sample Analysis: Blood biomarker samples (ctDNA)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Sample management, Sample Collection Kits, Sample Transportation Services, Tumor Tissue Sample Testing (PD-L1 and TNBC assessments)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
BNT327
Active Substance
BNT327
Modality
Peptide/protein/enzyme
Routes Of Administration
SOLUTION FOR INTRAVENOUS INFUSION
Route
SOLUTION FOR INTRAVENOUS INFUSION
Authorisation Status
Not authorised / Investigational
Maximum Dose
95.2 mg (maxDailyDoseAmount) / maxTotalDoseAmount 2000 mg
Investigational Product Name
BNT327 Placebo
Modality
Other
Authorisation Status
Not applicable
Investigational Product Name
PACLITAXEL
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
OTHER USE
Route
OTHER USE
Authorisation Status
Not authorised / Investigational (product entry has no marketing authorisation number in CTIS product record)
Maximum Dose
3.8 mg/m2 (maxDailyDoseAmount) / maxTotalDoseAmount 80 mg/m2
Investigational Product Name
Abraxane 5 mg/ml powder for dispersion for infusion.
Active Substance
PACLITAXEL ALBUMIN-BOUND
Modality
Small molecule
Routes Of Administration
OTHER USE
Route
OTHER USE
Authorisation Status
Authorised (EU marketing authorisation EU/1/07/428/001)
Maximum Dose
3.57 mg/m2 (maxDailyDoseAmount) / maxTotalDoseAmount 100 mg/m2
Investigational Product Name
GEMCITABINE
Active Substance
GEMCITABINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INTRAVENOUS INFUSION
Route
SOLUTION FOR INTRAVENOUS INFUSION
Authorisation Status
Not authorised / Investigational (product entry has no marketing authorisation number in CTIS product record)
Maximum Dose
47.62 mg/m2 (maxDailyDoseAmount) / maxTotalDoseAmount 1000 mg/m2
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INTRAVENOUS INFUSION
Route
SOLUTION FOR INTRAVENOUS INFUSION
Authorisation Status
Not authorised / Investigational (product entry has no marketing authorisation number in CTIS product record)
Maximum Dose
10.5 (dose unit 'Other' indicated as maxDailyDoseAmount) / maxTotalDoseAmount 2
Investigational Product Name
ERIBULIN
Active Substance
ERIBULIN MESYLATE
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INTRAVENOUS INFUSION
Route
SOLUTION FOR INTRAVENOUS INFUSION
Authorisation Status
Not authorised / Investigational (product entry has no marketing authorisation number in CTIS product record)
Maximum Dose
0.06 mg/m2 (maxDailyDoseAmount) / maxTotalDoseAmount 1.4 mg/m2
Combination Treatment
Yes

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