Clinical trial • Phase III • Oncology

IFINATAMAB DERUXTECAN for Esophageal squamous cell carcinoma

Phase III trial of IFINATAMAB DERUXTECAN for Esophageal squamous cell carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Esophageal squamous cell carcinoma
Trial Stage
Phase III
Drug Modality
ADC|Small molecule

Key dates

Initial CTIS Submission Date
25-02-2025
First CTIS Authorization Date
17-06-2025

Trial design

Randomised, open-label, experimental: ifinatamab deruxtecan (i-dxd) 12 mg/kg iv on day 1 of each 21-day cycle (q3w) until progression/unacceptable toxicity/discontinuation; comparator: investigator’s choice of chemotherapy (icc) — paclitaxel, docetaxel, or irinotecan hcl as per investigator’s choice and per locally approved label (dosing per local label).-controlled Phase III trial in Belgium, Italy, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Experimental: Ifinatamab deruxtecan (I-DXd) 12 mg/kg IV on Day 1 of each 21-day cycle (Q3W) until progression/unacceptable toxicity/discontinuation; Comparator: Investigator’s Choice of Chemotherapy (ICC) — paclitaxel, docetaxel, or irinotecan HCl as per investigator’s choice and per locally approved label (dosing per local label).
Target Sample Size
312

Eligibility

Recruits 312 The trial indicates vulnerable population selection (isVulnerablePopulationSelected = true). Inclusion requires subjects aged ≥18 years and states: "follow local regulatory requirements if the legal age of consent for study participation is >18 years old." Informed consent must therefore follow local regulations for legal age of consent; additional vulnerable-population-specific procedures are not detailed in the available CTIS data..

Vulnerable Population
The trial indicates vulnerable population selection (isVulnerablePopulationSelected = true). Inclusion requires subjects aged ≥18 years and states: "follow local regulatory requirements if the legal age of consent for study participation is >18 years old." Informed consent must therefore follow local regulations for legal age of consent; additional vulnerable-population-specific procedures are not detailed in the available CTIS data.

Inclusion criteria

  • {"criterion_text":"- Subjects aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).\n- Has histologically or cytologically documented unresectable locally advanced or metastatic ESCC\n- Has disease progression post platinum-based and ICI treatment per global or local guidelines, with a maximum of 1 prior line of systemic therapy for unresectable advanced or metastatic ESCC.\n- The subject must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.\n- Has at least 1 measurable lesion on computed tomography (CT)/ magnetic resonance imaging (MRI) according to RECIST v1.1 as assessed by the investigator.\n- Has an ECOG PS of 0 or 1 within 7 days prior to Cycle 1 Day 1."}

Exclusion criteria

  • {"criterion_text":"- Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.\n- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study randomization, severe asthma, chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc), and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren’s syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen.\n- Is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low dose inhaled steroids (for asthma/COPD), topical steroids (for mild skin conditions), or intra-articular steroid injections.\n- Has received any topoisomerase inhibitor.\n- Has histologically or cytologically confirmed adenosquamous carcinoma subtype or neuroendocrine features in >30% of tumor tissue.\n- Is ineligible to all the chemotherapies in the comparator arm due to prior progression or intolerance. Subjects who received paclitaxel or docetaxel in definitive chemoradiotherapy or neoadjuvant/adjuvant treatment (chemotherapy or chemoradiotherapy) settings whose disease progressed after 6 months of treatment completion are eligible.\n- Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of bleeding or fistula as assessed by the investigator.\n- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive or treated brain metastases who are asymptomatic (ie, without neurologic signs or symptoms and not requiring treatment with corticosteroids or anticonvulsants) may be included in the study. Subjects must have a stable neurologic status and discontinue corticosteroid usage for at least 2 weeks prior to Screening.\n- Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n- Has a clinically significant corneal disease.\n- Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD or ILD that cannot be ruled out by imaging at Screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- OS is defined as the time interval from the date of randomization to the date of death due to any cause.","definition_or_measurement_approach":"OS is defined as the time interval from the date of randomization to the date of death due to any cause."}

Secondary endpoints

  • {"endpoint_text":"- PFS is defined as the time interval from the date of randomization to the first date of disease progression as determined by BICR per RECIST v1.1 or death due to any cause, whichever occurs first.","definition_or_measurement_approach":"PFS measured by blinded independent central review (BICR) per RECIST v1.1 or death, whichever occurs first."}
  • {"endpoint_text":"- ORR is defined as the proportion of subjects with a BOR of confirmed CR or confirmed PR as assessed by BICR per RECIST v1.1.","definition_or_measurement_approach":"ORR = proportion with best overall response (confirmed CR or PR) assessed by BICR per RECIST v1.1."}
  • {"endpoint_text":"- DoR is defined as the time from the date of first documentation of objective tumor response (CR or PR), which is subsequently confirmed by BICR assessment, to the first documentation of objective tumor progression (confirmed by BICR) or to death due to any cause, whichever occurs first. TTR is defined as the time from randomization to the date of the first documentation of objective response by BICR assessment in responders (BOR of confirmed CR or confirmed PR).","definition_or_measurement_approach":"DoR measured from first documented (and BICR-confirmed) CR/PR to BICR-confirmed progression or death; TTR measured from randomization to first BICR-documented objective response."}
  • {"endpoint_text":"- DCR is defined as the proportion of subjects with a BOR of confirmed CR, confirmed PR, or SD according to RECIST v1.1 and will be determined by BICR assessment review of tumor scans.","definition_or_measurement_approach":"DCR = proportion with BOR of confirmed CR, confirmed PR, or SD per RECIST v1.1 assessed by BICR."}
  • {"endpoint_text":"- The following subscales from validated instruments will be used to assess PROs: EORTC QLQ-C30 – Global Health Status/Quality of Life scale, physical functioning, and fatigue EORTC OES18 – Dysphagia, trouble with eating, reflux, and pain. Change in scores from baseline throughout the Treatment Period will be measured for each scale.","definition_or_measurement_approach":"PROs assessed using EORTC QLQ-C30 (Global Health Status/QoL, physical functioning, fatigue) and EORTC OES18 (dysphagia, eating trouble, reflux, pain); change from baseline during treatment measured."}
  • {"endpoint_text":"- Incidence of TEAEs, serious TEAEs, and AESIs graded according to the NCI‑CTCAE v5.0, including deaths, changes from baseline in vital signs, clinical laboratory results, ECGs, and ECHO/MUGA.","definition_or_measurement_approach":"Safety measured as incidence and severity (NCI‑CTCAE v5.0) of TEAEs, serious TEAEs, AESIs, deaths, and changes from baseline in vitals, labs, ECG, and ECHO/MUGA."}
  • {"endpoint_text":"- ADA measured in plasma with a validated assay. ADA prevalence: The proportion of subjects who are ADA positive at any point in time (including pre existing ADA at baseline and treatment emergent ADA). ADA incidence: The proportion of subjects having treatment emergent ADA. Titer and neutralizing antibodies will be determined when the ADA is positive.","definition_or_measurement_approach":"Immunogenicity assessed by validated ADA assay in plasma; report prevalence, incidence, titers, and neutralizing antibodies when ADA positive."}
  • {"endpoint_text":"- B7-H3 protein expression in tumor tissue at baseline as determined by IHC and correlation with OS and other efficacy endpoints","definition_or_measurement_approach":"B7-H3 expression determined by IHC on baseline tumor tissue and correlated with OS and other efficacy endpoints."}
  • {"endpoint_text":"- Plasma concentrations at each time point and PK parameters (Cmax, Tmax, AUClast, and AUCtau) for I DXd, total anti B7-H3 antibody, and DXd in the full PK subset.","definition_or_measurement_approach":"PK analysis measuring plasma concentrations and parameters (Cmax, Tmax, AUClast, AUCtau) for I-DXd, anti-B7-H3 antibodies, and DXd in PK subset."}

Recruitment

Planned Sample Size
312
Recruitment Window Months
41
Consent Approach
Informed consent is obtained from adult subjects (subjects aged ≥18 years). The protocol states: "follow local regulatory requirements if the legal age of consent for study participation is >18 years old." Subject information and informed consent forms (ICFs) and related materials are available in multiple language versions (examples in the dossier: English, Dutch, French, Italian, Spanish, German, Polish, Romanian, Danish, Norwegian, Swedish). Additional consent materials include Pregnant Partner ICFs and privacy/GDPR attachments where applicable.

Methods

  • Doctor-to-patient letters (physician-led channel) — country-specific doctor-to-patient letters present in the recruitment materials (multiple language/country versions).
  • Patient brochures / Patient study guides — patient-facing brochures and participant guides available in multiple languages/country-specific versions.
  • Physician referral letters — materials for physician referral to the study (country-specific versions).
  • Clinical Study Site Patient Information Guide and Participant Study Guides — site-level informational materials for potential participants.
  • Patient wallet / ID cards — site-issued patient identification/wallet cards (country versions listed).
  • K1/K2 recruitment arrangements and recruitment procedure documents (country-specific) that summarize recruitment channels and materials.

Geography

Total Number Of Sites
84
Total Number Of Participants
312

Belgium

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
10-10-2025
Processing Time Days
144
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Institut Jules Bordet
Department Name
Oncology
Contact Person Name
Ana Maria Bucalau
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Oncology
Contact Person Name
Marc Van Den Eynde
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Oncology
Contact Person Name
Hans Prenen
Contact Person Email
hans.prenen@uza.be
Site Name
UZ Leuven
Department Name
Oncology
Contact Person Name
Jeroen Dekervel
Contact Person Email
jeroen.dekervel@uzleuven.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Oncology
Contact Person Name
Joelle Collignon
Contact Person Email
joelle.collignon@chuliege.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Oncology
Contact Person Name
Eduard Callebout
Contact Person Email
eduard.callebout@uzgent.be

Italy

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
11-11-2025
Processing Time Days
179
Number Of Sites
12
Number Of Participants
17

Sites

Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Oncologia Medica 2 universitaria
Contact Person Name
Lorenzo Fornaro
Contact Person Email
lorenzo.fornaro@gmail.com
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Medical Oncology
Contact Person Name
Silvia Foti
Contact Person Email
foti.silvia@hsr.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Oncology
Contact Person Name
Mario Airoldi
Contact Person Email
mairoldi55@gmail.com
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Uoc Oncologia Medica-Ematologica
Contact Person Name
Giampaolo Tortora
Site Name
Humanitas Mirasole S.p.A.
Department Name
Unit of Oncology and Hematology
Contact Person Name
Armando Santoro
Site Name
National Institute Of Gastroenterology Saverio De Bellis Research Hospital
Department Name
Medical Oncology Unit
Contact Person Name
Claudio Lotesoriere
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Medicina Interna - SOD Clinica Oncologica
Contact Person Name
Rossana Berardi
Site Name
Istituto Oncologico Veneto
Department Name
Oncology Department
Contact Person Name
Sara Lonardi
Contact Person Email
sara.lonardi@iov.veneto.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Medical Oncology
Contact Person Name
Filippo Pietrantonio
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Medical Oncology Unit 1
Contact Person Name
Annamaria Pessino
Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
Oncology Operative Unit
Contact Person Name
Emiliano Tamburini
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Uoc Oncologia Medica-Ematologica
Contact Person Name
Ferdinando De Vita

Spain

Earliest CTIS Part Ii Submission Date
05-05-2025
Latest Decision Or Authorization Date
15-10-2025
Processing Time Days
163
Number Of Sites
14
Number Of Participants
24

Sites

Site Name
Hospital Del Mar
Department Name
Oncology
Contact Person Name
Laura Visa Turmo
Contact Person Email
lvisa@psmar.cat
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Contact Person Name
Carmen Reyna Fortes
Contact Person Email
c.reyna.fortes@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Mariona Calvo Campos
Contact Person Email
mcalvo@iconcologia.net
Site Name
Hospital General Universitario De Elche
Department Name
Oncology
Contact Person Name
Javier Gallego Plazas
Contact Person Email
j.gallegoplazas@gmail.com
Site Name
Complejo Hospitalario Universitario De Ourense
Department Name
Oncology
Contact Person Name
Ana Fernandez Montes
Contact Person Email
ana.fernandez.montes@sergas.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Contact Person Name
Paula Richart Aznar
Contact Person Email
paularichart@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Federico Longo Muñoz
Contact Person Email
fedelongomunoz@hotmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Aitana Calvo Ferrándiz
Contact Person Email
aitanacalvo@hotmail.com
Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Contact Person Name
María Alsina Maqueda
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Contact Person Name
Fernando Rivera Herrero
Contact Person Email
fernando.rivera@scsalud.es
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncology
Contact Person Name
Paula Jimenez Fonseca
Contact Person Email
palucaji@hotmail.com
Site Name
Hospital Universitario De Burgos
Department Name
Oncology
Contact Person Name
Ana Maria Lopez Muñoz
Contact Person Email
alopezmu@saludcastillayleon.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Daniel Alejandro Acosta Eyzaguirre
Contact Person Email
dacosta@vhio.net
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
Juan Jose Reina Zoilo
Contact Person Email
juanjoreinaz@yahoo.es

France

Earliest CTIS Part Ii Submission Date
28-04-2025
Latest Decision Or Authorization Date
13-10-2025
Processing Time Days
168
Number Of Sites
17
Number Of Participants
66

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Digestive Oncology
Contact Person Name
Aziz Zaanan
Contact Person Email
aziz.zaanan@aphp.fr
Site Name
Hopital Saint Antoine
Department Name
Medical oncology
Contact Person Name
Romain Cohen
Contact Person Email
romain.cohen@aphp.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncology
Contact Person Name
Jean-Philippe Metges
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Contact Person Name
Emmanuelle Samalin
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Medical Oncology
Contact Person Name
Anthony Turpin
Contact Person Email
anthony.turpin@chu-lille.fr
Site Name
Centre Antoine Lacassagne
Department Name
Medical Oncology
Contact Person Name
Ludovic Evesque
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hepatogastroenterology and digestive oncology
Contact Person Name
Eric Terrebonne
Site Name
Institut Paoli Calmettes
Department Name
Medical Oncology
Contact Person Name
Christelle De la Fouchardiere
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Clélia Coutzac
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Medical Oncology
Contact Person Name
Nadim Fares
Contact Person Email
fares.n@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Medical Oncology
Contact Person Name
Yann Touchefeu
Contact Person Email
yann.touchefeu@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Gastro enterology and medical oncology
Contact Person Name
David Tougeron
Contact Person Email
david.tougeron@chu-poitiers.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Medical oncology
Contact Person Name
Julien Edeline
Contact Person Email
j.edeline@rennes.unicancer.fr
Site Name
Institut Curie
Department Name
Medical Oncology
Contact Person Name
Cindy Neuzillet
Contact Person Email
cindy.neuzillet@curie.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Medical Oncology
Contact Person Name
François Ghiringhelli
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Medical Oncology
Contact Person Name
Meher Ben Abdelghani
Contact Person Email
m.ben-abdelghani@icans.eu
Site Name
Institut Sainte Catherine
Department Name
Oncology - radiotherapy
Contact Person Name
Laurent Mineur
Contact Person Email
l.mineur@isc84.org

Romania

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
15-10-2025
Processing Time Days
149
Number Of Sites
7
Number Of Participants
13

Sites

Site Name
Institutul Clinic Fundeni
Department Name
Medical Oncology
Contact Person Name
Adina Emilia Croitoru
Contact Person Email
adina.croitoru09@yahoo.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Medical Oncology
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Memorial Healthcare International S.R.L.
Department Name
Medical Oncology
Contact Person Name
Ingrid Adriana Iordan
Contact Person Email
ingrid.iordan@memorial.ro
Site Name
Sigmedical Services S.R.L.
Department Name
Medical Oncology
Contact Person Name
Doina Elena Ganea
Contact Person Email
motan_doina@yahoo.com
Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Oncology
Contact Person Name
Constantin Volovat
Contact Person Email
cvolovat@yahoo.com
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncology
Contact Person Name
Andrei Ungureanu
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie Medicala II
Contact Person Name
Alina Simona Muntean
Contact Person Email
muntean.alina@yahoo.fr

Poland

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
15-10-2025
Processing Time Days
149
Number Of Sites
3
Number Of Participants
24

Sites

Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Siedleckie Centrum Onkologii, Oddział Onkologii Klinicznej i Radioterapii
Contact Person Name
Lubomir Bodnar
Contact Person Email
lbodnar@szpital.siedlce.pl
Site Name
Zanamed Medical Clinic Sp. z o.o.
Contact Person Name
Ludmiła Grzybowska-Szatkowska
Contact Person Email
Ludmila.szatkowska@zanamed.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Centrum Wsparcia Badań Klinicznych, Poradnia Onkologiczna CWBK
Contact Person Name
Szymon Borowiec
Contact Person Email
sborowiec@wim.mil.pl

Sweden

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
10-10-2025
Processing Time Days
147
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
KPE Verksamhetsområde Onkologi
Contact Person Name
Jan Nyman
Contact Person Email
jan.nyman@vgregion.se
Site Name
Karolinska University Hospital
Department Name
ME Huvud-,Hals-Lunga- och Hudcancer
Contact Person Name
Hanna Carstens

Netherlands

Earliest CTIS Part Ii Submission Date
06-06-2025
Latest Decision Or Authorization Date
13-10-2025
Processing Time Days
129
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Medical Oncology
Contact Person Name
Harm Westdorp
Contact Person Email
Harm.Westdorp@radboudumc.nl
Site Name
Amsterdam UMC Stichting
Department Name
Medical Oncology
Contact Person Name
Hanneke van Laarhoven
Contact Person Email
h.vanlaarhoven@amsterdamumc.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Medical Oncology
Contact Person Name
Vollebergh Mariek
Contact Person Email
m.vollebergh@nki.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Medical Oncology
Contact Person Name
Fredericus Eskens
Contact Person Email
f.eskens@erasmusmc.nl

Norway

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
15-10-2025
Processing Time Days
149
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Helse Stavanger HF
Department Name
Clinical Cancer Research
Contact Person Name
Herish Garresori
Contact Person Email
herish.garresori@sus.no
Site Name
Akershus University Hospital
Department Name
Medical Oncology
Contact Person Name
Asa Dahle Smith
Contact Person Email
asa.dahle.smith@ahus.no
Site Name
Sorlandet Sykehus HF
Department Name
Oncology
Contact Person Name
Camilla Norbakk Saevereide
Contact Person Email
camsae@sshf.no

Germany

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
359
Number Of Sites
12
Number Of Participants
18

Sites

Site Name
Klinikum Nuernberg
Department Name
Medizinische Klinik 5 (Oncology, Hematology)
Contact Person Name
Gabriele Siegler
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik f. Innere Medizin III
Contact Person Name
Mathias Hänel
Contact Person Email
m.haenel@skc.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik fuer Innere Medizin II
Contact Person Name
Udo Lindig
Contact Person Email
udo.lindig@med.uni-jena.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Innere Medizin - Schwerpunkt Haematol. u. Onko.
Contact Person Name
Peter Thuss-Patience
Contact Person Email
peter.thuss@vivantes.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Innere Medizin I, Gastroenterologie, Hepatologie
Contact Person Name
Michael Bitzer
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Department of Oncology with Section Hematology
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com
Site Name
Universitaet Leipzig
Department Name
Universitaeres Krebszentrum Leipzig (UCCL)
Contact Person Name
Florian Lordick
Site Name
Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative Onkologie
Contact Person Name
Alexander Stein
Contact Person Email
stein@hope-hamburg.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Medizinische Klinik und Poliklinik, Bereich Klinische Studien
Contact Person Name
Gunnar Folprecht
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie (CVK)
Contact Person Name
Annika Kurreck
Contact Person Email
annika.kurreck@charite.de
Site Name
Krankenhaus Nordwest GmbH
Department Name
Neurologische Klinik
Contact Person Name
Thorsten Goetze
Contact Person Email
goetze.thorsten@khnw.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik I, Gastroenterologie
Contact Person Name
Maria Gonzalez-Carmona

Denmark

Earliest CTIS Part Ii Submission Date
02-06-2025
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
345
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Region Midtjylland
Department Name
Oncology
Contact Person Name
Lise Thorsen
Site Name
Aalborg University Hospital
Department Name
Oncology
Contact Person Name
Signe Christensen
Contact Person Email
signe.christensen@rn.dk
Site Name
Rigshospitalet
Department Name
Hematology
Contact Person Name
Lene Bæksgaard
Site Name
Odense University Hospital
Department Name
Oncology
Contact Person Name
Line Tarpgaard
Contact Person Email
line.tarpgaard@rsyd.dk

Sponsor

Primary sponsor

Full Name
Daiichi Sankyo Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
IQVIA Limited
Responsibilities
codes:1,10,11,12,13,2,5,9
Name
Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.
Responsibilities
code:4
Name
PPD Development LP
Responsibilities
code:4
Name
Fortrea Inc.
Responsibilities
codes:10,6
Name
Suvoda LLC
Responsibilities
code:3
Name
Bioclinica Inc.
Responsibilities
value:Imaging (code:15)
Name
Medidata Solutions Inc.
Responsibilities
code:7
Name
Cisys Inc.
Responsibilities
value:patient eligibility (code:15)

Third parties

  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"codes:1,10,11,12,13,2,5,9","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"value:ePRO / eCOA (code:15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"codes:10,6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cisys Inc.","duties_or_roles":"value:patient eligibility (code:15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"value:Imaging (code:15)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"value:long-term storage of biological samples (code:15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"code:4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Japan","full_name":"Daiichi Sankyo Rd Novare Co. Ltd.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Ifinatamab deruxtecan (DS-7300a, I-DXd)
Active Substance
IFINATAMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
prodAuthStatus:1
Starting Dose
12 mg/kg
Dose Levels
12 mg/kg
Frequency
Every 21 days (Q3W)
Maximum Dose
12 mg/kg
Investigational Product Name
IRINOTECAN HYDROCHLORIDE
Active Substance
IRINOTECAN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
prodAuthStatus:2
Frequency
Per locally approved label (investigator's choice)
Maximum Dose
180 mg/m2
Investigational Product Name
PACLITAXEL
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
prodAuthStatus:2
Frequency
Per locally approved label (investigator's choice)
Maximum Dose
175 mg/m2
Investigational Product Name
DOCETAXEL
Active Substance
DOCETAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
prodAuthStatus:2
Frequency
Per locally approved label (investigator's choice)
Maximum Dose
75 mg/m2

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