Clinical trial • Phase III • Oncology

DATOPOTAMAB DERUXTECAN for Triple negative breast cancer | Hormone receptor-low HER2-negative breast cancer

Phase III trial of DATOPOTAMAB DERUXTECAN for Triple negative breast cancer | Hormone receptor-low HER2-negative breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Triple negative breast cancer | Hormone receptor-low HER2-negative breast cancer
Trial Stage
Phase III
Drug Modality
ADC | Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
17-11-2023
First CTIS Authorization Date
12-03-2024

Trial design

Randomised, open-label, neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy. comparator chemotherapy agents listed include doxorubicin, carboplatin, paclitaxel, epirubicin, capecitabine, cyclophosphamide (doses and schedules not specified in the available record).-controlled Phase III trial in Spain, Poland, Austria and others.

Randomised
Yes
Open Label
Yes
Comparator
Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy. Comparator chemotherapy agents listed include doxorubicin, carboplatin, paclitaxel, epirubicin, capecitabine, cyclophosphamide (doses and schedules not specified in the available record).
Target Sample Size
1399

Eligibility

Recruits 1399 Only adults (≥18) are eligible. Informed consent is required from adult participants using subject information sheets and informed consent forms. Separate ICF documents are provided for pregnant partners and for optional genetic research (country/site-specific ICFs are available). No procedures for assent (children) are described because children are excluded..

Pregnancy Exclusion
For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant.
Vulnerable Population
Only adults (≥18) are eligible. Informed consent is required from adult participants using subject information sheets and informed consent forms. Separate ICF documents are provided for pregnant partners and for optional genetic research (country/site-specific ICFs are available). No procedures for assent (children) are described because children are excluded.

Inclusion criteria

  • {"criterion_text":"- Participant must be ≥ 18 years, at the time of signing the ICF."}
  • {"criterion_text":"- Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer"}
  • {"criterion_text":"- ECOG PS of 0 or 1"}
  • {"criterion_text":"- Provision of acceptable tumour sample"}
  • {"criterion_text":"- Adequate bone marrow reserve and organ function"}
  • {"criterion_text":"- Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies; and in alignment with protocol requirements."}

Exclusion criteria

  • {"criterion_text":"- History of any prior invasive breast malignancy"}
  • {"criterion_text":"- History of another primary malignancy except for non-breast malignancy treated with curative intent with no known active disease within 5 years before randomisation"}
  • {"criterion_text":"- Evidence of distant disease."}
  • {"criterion_text":"- Clinically significant corneal disease."}
  • {"criterion_text":"- Has active or uncontrolled hepatitis B or C virus."}
  • {"criterion_text":"- Known HIV infection that is not well controlled."}
  • {"criterion_text":"- Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals"}
  • {"criterion_text":"- Known to have active tuberculosis infection"}
  • {"criterion_text":"- Mean resting corrected QTcF interval > 470 ms obtained from ECG"}
  • {"criterion_text":"- Uncontrolled or significant cardiac disease."}
  • {"criterion_text":"- History of non-infectious ILD/pneumonitis"}
  • {"criterion_text":"- Has severe pulmonary function compromise"}
  • {"criterion_text":"- Any prior or concurrent surgery, radiotherapy or any systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer"}
  • {"criterion_text":"- For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant."}
  • {"criterion_text":"- Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer."}
  • {"criterion_text":"- Concurrent use of systemic hormone replacement therapy or oral hormonal contraception"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Endpoint Event free survival (EFS) is defined as the time from the date of randomisation until the date of the first occurrence of any of the following events: disease progression precluding surgery, disease recurrence (local, regional, distant, or contralateral), second primary invasive cancer (other than squamous or basal cell skin cancer), or relapse from prior malignancy, or death by any cause (in the absence of recurrence).","definition_or_measurement_approach":"EFS defined as time from randomisation to first occurrence of: disease progression precluding surgery; disease recurrence (local, regional, distant, or contralateral); second primary invasive cancer (other than squamous or basal cell skin cancer); relapse from prior malignancy; or death by any cause (in absence of recurrence)."}

Secondary endpoints

  • {"endpoint_text":"- Key Secondary: pathological complete response (pCR) rate is defined as the proportion of participants who have no evidence by haematoxylin and eosin staining of residual invasive disease or lymphovascular invasion at the time of definitive surgery in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by blinded central evaluation following completion of neoadjuvant systemic therapy per AJCC staging criteria (edition 8).","definition_or_measurement_approach":"pCR rate defined as proportion with no residual invasive disease or lymphovascular invasion (ypT0/Tis ypN0) in resected breast specimen and sampled regional nodes by blinded central evaluation after neoadjuvant therapy per AJCC (8th ed.)."}
  • {"endpoint_text":"- Key secondary- overall survival (OS) is defined as the time from the date of randomisation until the date of death due to any cause.","definition_or_measurement_approach":"OS defined as time from randomisation until death from any cause."}
  • {"endpoint_text":"- Distant disease-free survival (DDFS) is defined as the time from the date of randomisation until the date of the first occurrence of any of the following events: distant metastasis, occurrence of second primary invasive cancer (other than squamous or basal cell skin cancer), relapse from prior malignancy or death by any cause (in the absence of recurrence).","definition_or_measurement_approach":"DDFS defined as time from randomisation to first occurrence of distant metastasis, second primary invasive cancer (excluding certain skin cancers), relapse from prior malignancy, or death (in absence of recurrence)."}

Recruitment

Planned Sample Size
1399
Recruitment Window Months
77
Consent Approach
Informed consent is obtained from adult participants (≥18) using subject information sheets and informed consent forms. Separate ICFs are provided for pregnant partners and for optional genetic research. Site- and country-specific ICFs and patient information materials are available (documents indicate translations and country-specific versions for Austria, Poland, Hungary, France, Belgium, Germany, Spain, Italy, etc.).

Geography

Total Number Of Sites
84
Total Number Of Participants
501

Spain

Earliest CTIS Part Ii Submission Date
30-11-2023
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
802
Number Of Sites
10
Number Of Participants
66

Sites

Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Contact Person Name
Alexandra Cortegoso Mosquera
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Mafalda Oliveira
Contact Person Email
moliveira@vhio.net
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
Luis de la Cruz Merino
Contact Person Email
ldelacruzmerino@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Olga Martínez Sáez
Contact Person Email
olmartinez@clinic.cat
Site Name
Hospital Beata Maria Ana
Department Name
Oncology
Contact Person Name
Javier Cortés Castán
Contact Person Email
jacortes@vhio.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Noelia Martínez Jañez
Contact Person Email
mjnoelia@hotmail.com
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Oncology
Contact Person Name
Isabel Blancas López-Barajas
Contact Person Email
isabelblancas@hotmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Agostina Stradella
Contact Person Email
astradella@iconcologia.net
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncology
Contact Person Name
Raquel Andrés Conejero
Contact Person Email
randres@salud.aragon.es
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Oncology
Contact Person Name
Isabel Blancas López-Barajas
Contact Person Email
isabelblancas@hotmail.com

Poland

Earliest CTIS Part Ii Submission Date
05-03-2024
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
706
Number Of Sites
9
Number Of Participants
41

Sites

Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddzial Onkologii Klinicznej Im. Dr Ewy Pileckiej z Pododzialem Chemioterapii Dziennej
Contact Person Name
Bogumila Czartoryska-Arlukowicz
Contact Person Email
bo.arlukowicz@gmail.com
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii I Radioterapii
Contact Person Name
Elzbieta Senkus-Konefka
Contact Person Email
elsenkus@gumed.edu.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddzial Kliniczny Onkologii oraz Poradnia Onkologiczna
Contact Person Name
Piotr Wysocki
Contact Person Email
piotr.wysocki@uj.edu.pl
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Oddział Onkologii I Radioterapii, Onkologia Kliniczna
Contact Person Name
Iwona Danielewicz
Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Klinika Onkologii
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Zurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
Site Name
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.
Department Name
Oddzial Onkologii Klinicznej
Contact Person Name
Magdalena Ciążyńska
Contact Person Email
ciazynska.magdalena@gmail.com
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Breast Unit
Contact Person Name
Malgorzata Pieniazek
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej
Contact Person Name
Zbigniew Nowecki
Contact Person Email
Zbigniew.Nowecki@nio.gov.pl

Austria

Earliest CTIS Part Ii Submission Date
26-02-2024
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
714
Number Of Sites
4
Number Of Participants
40

Sites

Site Name
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Department Name
Internal Medicine II at LKH Rankweil
Contact Person Name
Margit Sandholzer
Contact Person Email
margit.sandholzer@lkhf.at
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Abteilung für Innere Medizin III
Contact Person Name
Simon Gampenrieder
Contact Person Email
s.gampenrieder@salk.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
University Clinic for Gynaecology and Obstetrics
Contact Person Name
Daniel Egle
Contact Person Email
daniel.egle@tirol-kliniken.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Medical Oncology and Hematology
Contact Person Name
Clemens Dormann

France

Earliest CTIS Part Ii Submission Date
30-11-2023
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
802
Number Of Sites
13
Number Of Participants
70

Sites

Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Contact Person Name
Barbara PISTILLI
Site Name
Centre Francois Baclesse
Department Name
Medical Oncology
Contact Person Name
Georges EMILE
Contact Person Email
g.emile@baclesse.unicancer.fr
Site Name
Institut Sainte Catherine
Department Name
Medical Oncology
Contact Person Name
Julien GRENIER
Contact Person Email
j.grenier@isc84.org
Site Name
Centre Jean Perrin
Department Name
Medical Oncology
Contact Person Name
Marie-Ange MOURET-REYNIER
Site Name
Polyclinique De Limoges
Department Name
Medical Oncology
Contact Person Name
Dominique GENET
Contact Person Email
d.genet@imro.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Contact Person Name
Marie ALEXANDRE
Site Name
Hopital Saint Louis
Department Name
Medical Oncology
Contact Person Name
Sylvie GIACCHETTI
Contact Person Email
sylvie.giacchetti@aphp.fr
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Medical Oncology
Contact Person Name
Florence DALENC
Site Name
Institut Paoli-Calmettes
Department Name
Medical Oncology
Contact Person Name
Alexandre TASSIN DE NONNEVILLE
Site Name
Institut De Cancerologie De Lorraine
Department Name
Medical Oncology
Contact Person Name
Lionel UWER
Contact Person Email
l.uwer@nancy.unicancer.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Oncology
Contact Person Name
Thomas GRELLETY
Contact Person Email
tgrellety@ch-cotebasque.fr
Site Name
Centre Antoine Lacassagne
Department Name
Medical Oncology
Contact Person Name
Jean-Marc FERRERO
Site Name
Institut Godinot
Department Name
Medical Oncology
Contact Person Name
Christelle JOUANNAUD

Hungary

Earliest CTIS Part Ii Submission Date
22-01-2024
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
750
Number Of Sites
6
Number Of Participants
24

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
Mellkasi és Hasüregi Daganatok és Klinikai Farmakológiai Osztály "Kemoterápia B"
Contact Person Name
Zsuzsanna Németh
Contact Person Email
nemethstudy@gmail.com
Site Name
Tolna Varmegyei Balassa Janos Korhaz
Department Name
Onkológiai Osztály
Contact Person Name
Yousuf Al-Farhat
Contact Person Email
yalfarhat@gmail.com
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Osztály
Contact Person Name
Ágnes Wéber
Contact Person Email
dr.weber.agnes@szszbmk.hu
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Contact Person Name
Zsolt Horváth
Contact Person Email
horvathzso@kmk.hu
Site Name
Szent Lazar Megyei Korhaz
Department Name
Onkológiai Centrum
Contact Person Name
László Landherr
Contact Person Email
landherr@szlmk.hu
Site Name
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Department Name
Klinikai Onkológiai és Sugárterápiás Centrum
Contact Person Name
Gergely Dombovári
Contact Person Email
dombovaridr@freemail.hu

Bulgaria

Earliest CTIS Part Ii Submission Date
23-02-2024
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
738
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
Mbal Za Zhensko Zdrave Nadezhda OOD
Department Name
Clinic of medical oncology
Contact Person Name
Mila Petrova
Contact Person Email
milllapetrova@gmail.com
Site Name
University Specialized Hospital For Active Treatment In Oncology EAD
Department Name
Clinic of medical oncology
Contact Person Name
Asya Konsulova-Kirova
Contact Person Email
dr.konsoulova@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
30-11-2023
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
803
Number Of Sites
12
Number Of Participants
72

Sites

Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Oncologia ed Ematologia
Contact Person Name
Federico Piacentini
Contact Person Email
federico.piacentini@unimore.it
Site Name
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Department Name
Divisione di Oncologia
Contact Person Name
Alessandra Beano
Contact Person Email
abeano@cittadellasalute.to.it
Site Name
Azienda Unita Sanitaria Locale Toscana Nord Ovest
Department Name
Divisione di Oncologia
Contact Person Name
Editta Baldini
Site Name
Ospedale Generale Provinciale Di Macerata
Department Name
Dipartimento di Specialità Mediche-UOC Oncologia
Contact Person Name
Nicola Battelli
Site Name
Istituto Oncologico Veneto
Department Name
Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche
Contact Person Name
Valentina Guarneri
Contact Person Email
valentina.guarneri@unipd.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
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
Oncologia
Contact Person Name
Emiliano Tamburini
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Divisione di Oncologia
Contact Person Name
Michelino De Laurentiis
Site Name
Azienda USL Toscana Centro
Department Name
Divisione di Oncologia
Contact Person Name
Francesca Martella
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Scienze della Salute della donna, del bambino e di sanità pubblica
Contact Person Name
Alessandra Fabi
Site Name
Humanitas Research Hospital
Department Name
Unità Operativa di Oncologia ed Ematologia
Contact Person Name
Armando Santoro
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Oncologia
Contact Person Name
Stefania Russo

Belgium

Earliest CTIS Part Ii Submission Date
22-02-2024
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
747
Number Of Sites
6
Number Of Participants
50

Sites

Site Name
Grand Hopital De Charleroi
Department Name
Oncology & Hematology
Contact Person Name
Jean-Luc Canon
Contact Person Email
veronique.petre@ghdc.be
Site Name
UZ Leuven
Department Name
Medical Oncology
Contact Person Name
Hans Wildiers
Site Name
Algemeen Ziekenhuis Klina
Department Name
Oncology Hematology
Contact Person Name
Wim Demey
Contact Person Email
admin-EC@klina.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Medical Oncology
Contact Person Name
Aglaja De Pauw
Contact Person Email
studiesmedonc@uzgent.be
Site Name
Hopital De Libramont
Department Name
Oncology
Contact Person Name
Frédéric Forget
Contact Person Email
isabelle.baudesson@vivalia.be
Site Name
Ziekenhuis Aan De Stroom
Department Name
Medical Oncology
Contact Person Name
Kevin Punie
Contact Person Email
AOR@gza.be

Germany

Earliest CTIS Part Ii Submission Date
02-02-2024
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
811
Number Of Sites
22
Number Of Participants
127

Sites

Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik fuer Frauenheilkunde Brustzentrum
Contact Person Name
Jennifer Spoenlein
Contact Person Email
J.Spoenlein@kem-med.com
Site Name
Staedtisches Klinikum Dessau
Department Name
Klinik fuer Frauenheilkunde und Geburtshilfe
Contact Person Name
Hermann Voss
Site Name
Rotkreuzklinikum Muenchen gGmbH
Department Name
Gynaekologie
Contact Person Name
Michael Braun
Contact Person Email
michael.braun@swmbrk.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Nationales Centrum für Tumorerkrankungen
Contact Person Name
Andreas Schneeweiss
Site Name
Vivantes MVZ GmbH
Department Name
"Klinik fuer Innere Medizin Haematologie und Onkologie"
Contact Person Name
Claudia Gerber Schaefer
Site Name
Universitat Heidelberg
Department Name
Gynaekologische Onkologie
Contact Person Name
Frederik Marme
Contact Person Email
frederik.marme@umm.de
Site Name
Haematologie-Onkologie im Zentrum MVZ GmbH
Contact Person Name
Bernhard Juergen Heinrich
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Geburtshilfe und Gynaekologie
Contact Person Name
Michael Untch
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe
Contact Person Name
Pauline Wimberger
Site Name
Universitaetsklinikum Muenster AöR
Department Name
"Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe Brustzentrum"
Contact Person Name
Joke Tio
Contact Person Email
joke.tio@ukmuenster.de
Site Name
Ulm University
Department Name
Klinik fuer Frauenheilkunde und Geburtshilfe
Contact Person Name
Wolfgang Janni
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Frauenklinik
Contact Person Name
Peter Fasching
Site Name
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
Contact Person Name
Matthias Zaiss
Site Name
Medizinische Hochschule Hannover
Department Name
Gynaekologische Onkologie
Contact Person Name
Tjoung Won Park-Simon
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik und Poliklinik für Gynaekologie
Contact Person Name
Lisa Steinhilper
Contact Person Email
l.steinhilper@uke.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Klinik und Poliklinik fuer Frauenheilkunde
Contact Person Name
Evelyn Klein
Contact Person Email
evelyn.klein@tum.de
Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
"Klinik fuer Gynaekologie und Geburtshilfe Frauenheilkunde"
Contact Person Name
Marion van Mackelenbergh
Site Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Department Name
Gynaekologie und Geburtshilfe
Contact Person Name
Sebastian Jud
Contact Person Email
Sebastian.jud@mutterhaus.de
Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
Gynaekologisches Krebszentrum
Contact Person Name
Marc Thill
Contact Person Email
marc.thill@agaplesion.de
Site Name
Diakovere Krankenhaus gGmbH
Department Name
Frauenklinik
Contact Person Name
Kristina Luebbe
Contact Person Email
Kristina.Luebbe@diakovere.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik fuer Frauenheilkunde
Contact Person Name
Beate Rautenberg
Site Name
Klinikum Esslingen GmbH
Department Name
Klinik fuer Frauenheilkunde und Geburtshilfe
Contact Person Name
Alexander Hein
Contact Person Email
a.hein@klinikum-esslingen.de

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
Datopotamab deruxtecan
Active Substance
DATOPOTAMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Investigational Product Name
IMFINZI 50 mg/mL concentrate for solution for infusion.
Active Substance
DURVALUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
EU/1/18/1322/001
Investigational Product Name
PEMBROLIZUMAB
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Investigational Product Name
Doxorubicin
Active Substance
DOXORUBICIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Investigational Product Name
Carboplatin
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Investigational Product Name
Paclitaxel
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Investigational Product Name
Capecitabine
Active Substance
CAPECITABINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Investigational Product Name
Cyclophosphamide
Active Substance
CYCLOPHOSPHAMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Investigational Product Name
Epirubicin
Active Substance
EPIRUBICIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Investigational Product Name
Lynparza 150 mg film-coated tablets
Active Substance
OLAPARIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
EU/1/14/959/004
Investigational Product Name
Infliximab
Active Substance
INFLIXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Investigational Product Name
Mycophenolate Mofetil
Active Substance
MYCOPHENOLATE MOFETIL
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Combination Treatment
Yes

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