Clinical trial • Phase III • Oncology

IGG-LIKE T CELL ENGAGER BINDING TO DLL3 AND CD3 for Extrapulmonary neuroendocrine carcinoma (advanced or metastatic)

Phase III trial of IGG-LIKE T CELL ENGAGER BINDING TO DLL3 AND CD3 for Extrapulmonary neuroendocrine carcinoma (advanced or metastatic).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Extrapulmonary neuroendocrine carcinoma (advanced or metastatic)
Trial Stage
Phase III
Drug Modality
Bispecific antibody|Monoclonal antibody|Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
04-03-2026
First CTIS Authorization Date
13-05-2026

Trial design

Randomised, open-label, experimental arm: obrixtamig (bi 764532) administered intravenously in combination with carboplatin and etoposide. comparator (control) arm: carboplatin plus etoposide (standard first-line chemotherapy). cycle 0 dose specification (per inclusion criteria): cisplatin 75 mg/m2 or carboplatin auc 5 plus etoposide 80 mg/m2 (minimum) for the standard platinum + etoposide regimen prior to randomisation. Phase III trial in Belgium, Czechia, Denmark and others.

Randomised
Yes
Open Label
Yes
Comparator
Experimental arm: obrixtamig (BI 764532) administered intravenously in combination with carboplatin and etoposide. Comparator (control) arm: carboplatin plus etoposide (standard first-line chemotherapy). Cycle 0 dose specification (per inclusion criteria): cisplatin 75 mg/m2 or carboplatin AUC 5 plus etoposide 80 mg/m2 (minimum) for the standard platinum + etoposide regimen prior to randomisation.
Biomarker Stratified
True (DLL3 expression; only DLL3‑positive patients are enrolled)
Target Sample Size
246
Trial Duration For Participant
1080

Eligibility

Recruits 246 No vulnerable populations selected (isVulnerablePopulationSelected = false). The trial enrolls adults only: participants must be ≥18 years old (or at least the legal age of consent in countries where this is greater than 18) and provide informed consent via an ICF. Country-specific ICFs and related participant documents are provided in multiple languages; assent is not indicated because only adults are eligible..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected = false). The trial enrolls adults only: participants must be ≥18 years old (or at least the legal age of consent in countries where this is greater than 18) and provide informed consent via an ICF. Country-specific ICFs and related participant documents are provided in multiple languages; assent is not indicated because only adults are eligible.

Inclusion criteria

  • {"criterion_text":"- 1. Patients with poorly differentiated unresectable locally advanced or metastatic epNEC with Ki-67 >20% or mitotic rate mitotic rate with number of mitoses >20 per 2 mm2, regardless of primary site (including site of unknown origin)\n- 2. Patients with tumours with mixed histologies are eligible only if neuroendocrine carcinoma component is predominant and represents more than 70% of the overall tumour tissue\n- 3. No prior systemic treatment for unresectable locally advanced or metastatic epNEC (except for the completed one cycle of standard platinum + etoposide). Prior peri-operative chemotherapy or -radiation for curative intention is allowed if at least 6 months have elapsed between completion of this therapy and diagnosis of unresectable locally advanced or metastatic disease\n- 4. Patients who have finished one cycle of standard platinum + etoposide regimen as first-line treatment (Cycle 0: etoposide with carboplatin or cisplatin, administered at a minimum dose of cisplatin 75 mg/m2 or carboplatin AUC 5 and etoposide 80 mg/m2) prior to randomisation\n- 5. Patients must comply with criteria for receiving further chemotherapy treatment as first-line SoC treatment within 28 days after the start of the initial chemotherapy (Cycle 0)\n- 6. Adequate archival FFPE tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of DLL3 expression status. Tumours must be positive (as defined in the diagnostic study protocol) for DLL3 expression status assessed by investigational VENTANA DLL3 (SP347) RxDx Assay\n- 7. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n- 8. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF)\n- 9. Further inclusion criteria apply."}

Exclusion criteria

  • {"criterion_text":"- 1. Presence of leptomeningeal disease and/or carcinomatous meningitis\n- 2. Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma\n- 3. Patients with neuroendocrine prostate cancer\n- 4. Patients with well-differentiated neuroendocrine tumours of any grade according to the WHO classification, 5th edition\n- 5. Patients with a history of well differentiated NET tumour that transformed into poorly differentiated NEC\n- 6. Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. TcEs, cell therapies, antibody-drug conjugates, or radiopharmaceuticals)\n- 7. Previous treatment with anti-PD-1 or PD-L1 therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0)\n- 8. Toxicity from previous treatments that has not resolved to ≤ CTCAE Grade 1 or grade prior to Cycle 0. Participants with alopecia any grade, CTCAE ≤Grade 2 asthenia/fatigue, amenorrhea/menstrual disorders any grade, CTCAE ≤Grade 2 peripheral neuropathy, and/or CTCAE ≤Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per Investigator judgement may be eligible\n- 9. Further exclusion criteria apply."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival (OS), defined as the time from randomisation until death from any cause","definition_or_measurement_approach":"Defined as the time from randomisation until death from any cause (time-to-event endpoint)."}

Secondary endpoints

  • {"endpoint_text":"- PFS is defined as the time from randomisation until the earliest date of disease progression according to RECIST 1.1 based on investigator assessments or death from any cause, whichever occurs first","definition_or_measurement_approach":"Time from randomisation to earliest of disease progression per RECIST 1.1 (investigator assessed) or death."}
  • {"endpoint_text":"- Change from baseline to Week 19 in the physical functioning domain of the EORTC QLQ-C30","definition_or_measurement_approach":"Mean change from baseline to Week 19 in the EORTC QLQ-C30 physical functioning domain (patient-reported outcome)."}
  • {"endpoint_text":"- Objective response (OR) is defined as a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 (based on investigator assessments) from randomisation until the earliest date of disease progression, death, last evaluable tumour assessment before the start of next line of anti-cancer treatment, loss to follow-up, or withdrawal of consent","definition_or_measurement_approach":"Best overall response per RECIST 1.1 (CR or PR) assessed by investigator from randomisation until earliest of progression, death, last evaluable assessment before next-line therapy, loss to follow-up, or withdrawal."}
  • {"endpoint_text":"- DoR, defined as the time from the first documented OR according to RECIST 1.1 until the earliest date of disease progression or death among patients with objective response based on investigator assessments","definition_or_measurement_approach":"Time from first documented objective response (CR/PR) per RECIST 1.1 to earliest of progression or death among responders (investigator assessed)."}
  • {"endpoint_text":"- Disease control (DC), defined as best overall response of complete response (CR) or partial response (PR) or stable disease (SD) where best overall response is defined according to RECIST 1.1 based on investigator assessments from randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of next line of anti-cancer treatment, loss to follow-up or withdrawal of consent","definition_or_measurement_approach":"Best overall response per RECIST 1.1 (CR, PR or SD) from randomisation until earliest of progression, death, last evaluable tumour assessment before next-line therapy, loss to follow-up or withdrawal."}
  • {"endpoint_text":"- Occurrence of treatment-emergent Grade 3 or greater CRS","definition_or_measurement_approach":"Incidence of treatment-emergent cytokine release syndrome (CRS) of CTCAE Grade ≥3 during treatment period."}
  • {"endpoint_text":"- Occurrence of treatment-emergent Grade 3 or greater ICANS","definition_or_measurement_approach":"Incidence of treatment-emergent immune effector cell-associated neurotoxicity syndrome (ICANS) of CTCAE Grade ≥3 during treatment period."}
  • {"endpoint_text":"- Occurrence of treatment-emergent AEs leading to permanent discontinuation of trial medication during the on-treatment period","definition_or_measurement_approach":"Incidence of adverse events emerging on treatment that result in permanent discontinuation of trial medication during on-treatment period."}
  • {"endpoint_text":"- Occurrence of treatment-emergent AEs leading to dose modification of trial medication (i.e. dose interruption, dose delay, dose reduction)","definition_or_measurement_approach":"Incidence of treatment-emergent adverse events resulting in dose interruption, delay or reduction of trial medication."}

Recruitment

Planned Sample Size
246
Recruitment Window Months
46
Consent Approach
Informed consent is obtained via a signed informed consent form (ICF) by the participant (participants must be ≥18 years or at least the legal age of consent in that country). Country-specific ICFs and related participant information documents are provided in multiple languages (document list includes English, Dutch, German, French, Spanish, Italian, Portuguese, Polish, Finnish, Swedish, Norwegian, Czech, Danish and localized versions). Additional ICF variants (e.g., pregnant partner, biobanking, newborn) are provided where applicable.

Methods

  • Country-specific recruitment arrangements documented (k1/k2 recruitment arrangements files present for multiple countries).
  • Use of patient brochures and patient-facing survey/consent documents (country- and language-specific patient brochures and reminders are listed in submitted documents).
  • Use of clinic/clinician referral materials and site-based recruitment (Clinics/hospitals listed as sites across countries).
  • Use of participant travel support and administrative materials (Greenphire travel guides, travel contact cards, bank transfer FAQs/messages and Connex travel cards present in recruitment materials for some countries, notably Germany, Spain, Italy, etc.).
  • Appointment reminders and other study communications (appointment reminder and patient-reminder documents are present in document list).

Geography

Total Number Of Sites
66
Total Number Of Participants
134

Belgium

Earliest CTIS Part Ii Submission Date
26-04-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
17
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
General Medical Oncology
Principal Investigator Name
Ivan Borbath
Principal Investigator Email
ivan.borbath@saintluc.uclouvain.be
Contact Person Name
Ivan Borbath
Site Name
UZ Leuven
Department Name
General Medical Oncology
Principal Investigator Name
Chris Verslype
Principal Investigator Email
chris.verslype@uzleuven.be
Contact Person Name
Chris Verslype
Contact Person Email
chris.verslype@uzleuven.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
General Medical Oncology
Principal Investigator Name
Laurence Lousberg
Principal Investigator Email
laurence.lousberg@chuliege.be
Contact Person Name
Laurence Lousberg
Contact Person Email
laurence.lousberg@chuliege.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Medical Oncology
Principal Investigator Name
Timon Vandamme
Principal Investigator Email
timon.vandamme@uza.be
Contact Person Name
Timon Vandamme
Contact Person Email
timon.vandamme@uza.be

Czechia

Earliest CTIS Part Ii Submission Date
27-04-2026
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
17
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Masarykuv Onkologicky Ustav
Department Name
Clinical Trials Unit
Principal Investigator Name
Beatric Bencsikova
Principal Investigator Email
beatric.bencsikova@mou.cz
Contact Person Name
Beatric Bencsikova
Contact Person Email
beatric.bencsikova@mou.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Clinic of Oncology and Radiotherapy
Principal Investigator Name
Ondrej Kubecek
Principal Investigator Email
ondrej.kubecek@fnhk.cz
Contact Person Name
Ondrej Kubecek
Contact Person Email
ondrej.kubecek@fnhk.cz

Denmark

Earliest CTIS Part Ii Submission Date
07-05-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
6
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Rigshospitalet
Department Name
Department of Oncology Head, Lung Cancer and Neuroendocrine Center
Principal Investigator Name
Seppo Langer
Principal Investigator Email
seppo.langer@regionh.dk
Contact Person Name
Seppo Langer
Contact Person Email
seppo.langer@regionh.dk
Site Name
Region Midtjylland
Department Name
Kræftafdeling, Team B
Principal Investigator Name
Elizaveta Tabaksblat
Principal Investigator Email
eliza.mit.tab@auh.rm.dk
Contact Person Name
Elizaveta Tabaksblat
Contact Person Email
eliza.mit.tab@auh.rm.dk
Site Name
Odense University Hospital
Department Name
Onkologisk Afdeling R
Principal Investigator Name
Merete Krogh
Principal Investigator Email
merete.krogh@rsyd.dk
Contact Person Name
Merete Krogh
Contact Person Email
merete.krogh@rsyd.dk

Finland

Earliest CTIS Part Ii Submission Date
24-04-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
21
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
HUS-yhtymae
Department Name
Comprehensive Cancer Center
Principal Investigator Name
Tytti Ahola
Principal Investigator Email
tytti.ahola@hus.fi
Contact Person Name
Tytti Ahola
Contact Person Email
tytti.ahola@hus.fi
Site Name
Turku University Hospital
Department Name
medical oncology
Principal Investigator Name
Panu Jaakkola
Principal Investigator Email
panu.jaakkola@varha.fi
Contact Person Name
Panu Jaakkola
Contact Person Email
panu.jaakkola@varha.fi
Site Name
Pohjois-Savon hyvinvointialue
Department Name
Syöpätautien poliklinikka
Principal Investigator Name
Okko Kääriäinen
Principal Investigator Email
okko.kaariainen@pshyvinvointialue.fi
Contact Person Name
Okko Kääriäinen
Site Name
Pirkanmaan hyvinvointialue
Department Name
Onkologia, Radius, 2. krs
Principal Investigator Name
Pia Osterlund
Principal Investigator Email
pia.osterlund@pirha.fi
Contact Person Name
Pia Osterlund
Contact Person Email
pia.osterlund@pirha.fi

France

Earliest CTIS Part Ii Submission Date
24-04-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
21
Number Of Sites
8
Number Of Participants
16

Sites

Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Service oncologie médicale
Principal Investigator Name
Marc Pracht
Principal Investigator Email
m.pracht@rennes.unicancer.fr
Contact Person Name
Marc Pracht
Contact Person Email
m.pracht@rennes.unicancer.fr
Site Name
Institut Paoli Calmettes
Department Name
Service Oncologie Médicale
Principal Investigator Name
Sandrine Oziel-Taieb
Principal Investigator Email
OZIELS@ipc.unicancer.fr
Contact Person Name
Sandrine Oziel-Taieb
Contact Person Email
OZIELS@ipc.unicancer.fr
Site Name
Hospices Civils De Lyon
Department Name
Service oncologie médicale
Principal Investigator Name
Thomas Walter
Principal Investigator Email
thomas.walter@chu-lyon.fr
Contact Person Name
Thomas Walter
Contact Person Email
thomas.walter@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service oncologie médicale
Principal Investigator Name
Marion Jaffrelot
Principal Investigator Email
jaffrelot.m@chu-toulouse.fr
Contact Person Name
Marion Jaffrelot
Contact Person Email
jaffrelot.m@chu-toulouse.fr
Site Name
Hopital Beaujon
Department Name
Service de Pancréatologie et d’Oncologie Digestive
Principal Investigator Name
Louis De Mestier Du Bourg
Principal Investigator Email
louis.demestier@aphp.fr
Contact Person Name
Louis De Mestier Du Bourg
Contact Person Email
louis.demestier@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Unité de Recherche Clinique du service d’hépatogastroentérologie et oncologie digestive
Principal Investigator Name
Denis Smith
Principal Investigator Email
denis.smith@chu-bordeaux.fr
Contact Person Name
Denis Smith
Contact Person Email
denis.smith@chu-bordeaux.fr
Site Name
Institut Gustave Roussy
Department Name
service oncologie médicale
Principal Investigator Name
Julien Hadoux
Principal Investigator Email
julien.hadoux@gustaveroussy.fr
Contact Person Name
Julien Hadoux
Contact Person Email
julien.hadoux@gustaveroussy.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Service hépatogastroentérologie
Principal Investigator Name
Come Lepage
Principal Investigator Email
come.lepage@u-bourgogne.fr
Contact Person Name
Come Lepage
Contact Person Email
come.lepage@u-bourgogne.fr

Germany

Earliest CTIS Part Ii Submission Date
24-04-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
21
Number Of Sites
11
Number Of Participants
20

Sites

Site Name
DRK Kliniken Berlin
Department Name
Klinik für Innere Medizin - Gastroenterologie, Hämatologie und Onkologie, Nephrologie
Principal Investigator Name
Henning Jann
Principal Investigator Email
h.jann@drk-kliniken-berlin.de
Contact Person Name
Henning Jann
Contact Person Email
h.jann@drk-kliniken-berlin.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Schwerpunkt Endokrinologie und Stoffwechselerkrankungen; Endokrinologische Ambulanz
Principal Investigator Name
Matthias Weber
Principal Investigator Email
mmweber@uni-mainz.de
Contact Person Name
Matthias Weber
Contact Person Email
mmweber@uni-mainz.de
Site Name
Asklepios Klinik St George
Department Name
Asklepios Tumorzentrum Hamburg
Principal Investigator Name
Ulrich-Frank Pape
Principal Investigator Email
ul.pape@asklepios.com
Contact Person Name
Ulrich-Frank Pape
Contact Person Email
ul.pape@asklepios.com
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Anke Kröcher
Principal Investigator Email
Anke.Kroecher@uniklinikum-dresden.de
Contact Person Name
Anke Kröcher
Site Name
Medical Center - University Of Freiburg
Department Name
Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
Principal Investigator Name
Heiko Becker
Principal Investigator Email
heiko.becker@uniklinik-freiburg.de
Contact Person Name
Heiko Becker
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Abteilung Medizinische Onkologie, Nationales Centrum für Tumorerkrankungen (NCT)
Principal Investigator Name
Leonidas Apostolidis
Principal Investigator Email
Leonidas.Apostolidis@med.uni-heidelberg.de
Contact Person Name
Leonidas Apostolidis
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Klinik und Poliklinik II
Principal Investigator Name
Alexander Weich
Principal Investigator Email
weich_a@ukw.de
Contact Person Name
Alexander Weich
Contact Person Email
weich_a@ukw.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Innere Medizin VIII - Medizinische Onkologie und Pneumologie
Principal Investigator Name
Martina Hinterleitner
Principal Investigator Email
martina.hinterleitner@med.uni-tuebingen.de
Contact Person Name
Martina Hinterleitner
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Innere Medizin I Internistisches Zentrum Endokrinologie und Diabetologie
Principal Investigator Name
Marianne Pavel
Principal Investigator Email
marianne.pavel@uk-erlangen.de
Contact Person Name
Marianne Pavel
Contact Person Email
marianne.pavel@uk-erlangen.de
Site Name
Universitaet Muenster
Department Name
Medizinische Klinik A – Hämatologie, Onkologie und Pneumologie
Principal Investigator Name
Klaus Wethmar
Principal Investigator Email
Klaus.Wethmar@ukmuenster.de
Contact Person Name
Klaus Wethmar
Contact Person Email
Klaus.Wethmar@ukmuenster.de
Site Name
Universitaetsklinikum Koeln AöR
Department Name
Centrum für Integrierte Onkologie (CIO) Studienzentrum der Klinik I für Innere Medizin (CTU)
Principal Investigator Name
Anne Meister
Principal Investigator Email
Anne.Meister@uk-koeln.de
Contact Person Name
Anne Meister
Contact Person Email
Anne.Meister@uk-koeln.de

Italy

Earliest CTIS Part Ii Submission Date
30-04-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
13
Number Of Sites
8
Number Of Participants
16

Sites

Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
U.O.S. D.H. Oncologico
Principal Investigator Name
Bruno Vincenzi
Principal Investigator Email
b.vincenzi@unicampus.it
Contact Person Name
Bruno Vincenzi
Contact Person Email
b.vincenzi@unicampus.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
UOC Oncologia Medica
Principal Investigator Name
Giuseppe Badalamenti
Principal Investigator Email
giuseppe.badalamenti@unipa.it
Contact Person Name
Giuseppe Badalamenti
Contact Person Email
giuseppe.badalamenti@unipa.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Oncologia - (8° Piano Lotto B) c/o Policlinico “G.B. Rossi”
Principal Investigator Name
Sara Cingarlini
Principal Investigator Email
sara.cingarlini@aovr.veneto.it
Contact Person Name
Sara Cingarlini
Contact Person Email
sara.cingarlini@aovr.veneto.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SOD Oncologia
Principal Investigator Name
Lorenzo Antonuzzo
Principal Investigator Email
lorenzo.antonuzzo@unifi.it
Contact Person Name
Lorenzo Antonuzzo
Contact Person Email
lorenzo.antonuzzo@unifi.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
SC Oncologia Clinica e Sperimentale dei Sarcomi e dei Tumori Rari
Principal Investigator Name
Salvatore Tafuto
Principal Investigator Email
s.tafuto@istitutotumori.na.it
Contact Person Name
Salvatore Tafuto
Contact Person Email
s.tafuto@istitutotumori.na.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncologia Medica Gastrointestinale e Tumori Neuroendocrini
Principal Investigator Name
Nicola FAZIO
Principal Investigator Email
nicola.fazio@ieo.it
Contact Person Name
Nicola FAZIO
Contact Person Email
nicola.fazio@ieo.it
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
UOC Oncologia Medica Universitaria
Principal Investigator Name
Mauro Cives
Principal Investigator Email
mauro.cives@uniba.it
Contact Person Name
Mauro Cives
Contact Person Email
mauro.cives@uniba.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica
Principal Investigator Name
Sara Pusceddu
Principal Investigator Email
sara.pusceddu@istitutotumori.mi.it
Contact Person Name
Sara Pusceddu

Portugal

Earliest CTIS Part Ii Submission Date
24-04-2026
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
20
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Servico de Medicina Oncologica
Principal Investigator Name
Isabel Azevedo
Principal Investigator Email
isabel.azevedo.rocha@ipoporto.min-saude.pt
Contact Person Name
Isabel Azevedo
Site Name
Hospital CUF Porto S.A.
Department Name
Oncology Department
Principal Investigator Name
Carlos Sottomayor
Principal Investigator Email
carlos.sottomayor@jmellosaude.pt
Contact Person Name
Carlos Sottomayor
Site Name
Lusiadas S.A.
Department Name
Oncology Department
Principal Investigator Name
Daniela Macedo
Principal Investigator Email
daniela.gouveia.macedo@lusiadas.pt
Contact Person Name
Daniela Macedo
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Oncology Department
Principal Investigator Name
António Moreira
Principal Investigator Email
alritamoreira@gmail.com
Contact Person Name
António Moreira
Contact Person Email
alritamoreira@gmail.com
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Servico de Oncologia Medica
Principal Investigator Name
Luis Costa
Principal Investigator Email
luiscosta.oncology@gmail.com
Contact Person Name
Luis Costa
Contact Person Email
luiscosta.oncology@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
04-05-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
9
Number Of Sites
10
Number Of Participants
22

Sites

Site Name
Hospital Universitario De Navarra
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
David Gomez Sanchez
Principal Investigator Email
david.gomez.sanchez@navarra.es
Contact Person Name
David Gomez Sanchez
Contact Person Email
david.gomez.sanchez@navarra.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Servicio Oncologia Medica
Principal Investigator Name
Teresa Alonso Gordoa
Principal Investigator Email
talonsogordoa@gmail.com
Contact Person Name
Teresa Alonso Gordoa
Contact Person Email
talonsogordoa@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Unidad de Tumores Digestivos y Melanoma
Principal Investigator Name
Sofia Espana
Principal Investigator Email
sofia.ef@iconcologia.net
Contact Person Name
Sofia Espana
Contact Person Email
sofia.ef@iconcologia.net
Site Name
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Department Name
Medical Oncology
Principal Investigator Name
Desamparados Roda
Principal Investigator Email
derope@hotmail.com
Contact Person Name
Desamparados Roda
Contact Person Email
derope@hotmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Angela Lamarca Lete
Principal Investigator Email
angela.lamarca@quironsalud.es
Contact Person Name
Angela Lamarca Lete
Contact Person Email
angela.lamarca@quironsalud.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Jaume Capdevila
Principal Investigator Email
jcapdevila@vhio.net
Contact Person Name
Jaume Capdevila
Contact Person Email
jcapdevila@vhio.net
Site Name
Hospital Universitario Regional De Malaga
Department Name
Servicio Oncologia Medica
Principal Investigator Name
Inmaculada Alés Díaz
Principal Investigator Email
inales@hotmail.com
Contact Person Name
Inmaculada Alés Díaz
Contact Person Email
inales@hotmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Rocío García Carbonero
Principal Investigator Email
rgcarbonero@gmail.com
Contact Person Name
Rocío García Carbonero
Contact Person Email
rgcarbonero@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncología - Unidad de Inv. Clínica
Principal Investigator Name
Carlos Lopez Lopez
Principal Investigator Email
carlos.lopez@scsalud.es
Contact Person Name
Carlos Lopez Lopez
Contact Person Email
carlos.lopez@scsalud.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio Oncología
Principal Investigator Name
Marta Benavent
Principal Investigator Email
martabenaventv@gmail.com
Contact Person Name
Marta Benavent
Contact Person Email
martabenaventv@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
24-04-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
19
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Interne oncologie
Principal Investigator Name
Fredericus Eskens
Principal Investigator Email
f.eskens@erasmusmc.nl
Contact Person Name
Fredericus Eskens
Contact Person Email
f.eskens@erasmusmc.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Medische Oncologie
Principal Investigator Name
Margot Tesselaar
Principal Investigator Email
m.tesselaar@nki.nl
Contact Person Name
Margot Tesselaar
Contact Person Email
m.tesselaar@nki.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Department of Internal Medicine
Principal Investigator Name
Loes. M. Latten-Jansen
Principal Investigator Email
loes.jansen@mumc.nl
Contact Person Name
Loes. M. Latten-Jansen
Contact Person Email
loes.jansen@mumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Department of Medical Oncology / Room Z3.18
Principal Investigator Name
Derk Jan de Groot
Principal Investigator Email
d.j.a.de.groot@umcg.nl
Contact Person Name
Derk Jan de Groot
Contact Person Email
d.j.a.de.groot@umcg.nl

Norway

Earliest CTIS Part Ii Submission Date
07-05-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
6
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Helse Stavanger HF
Department Name
Kreftavdelingen
Principal Investigator Name
Herish Garresori
Principal Investigator Email
herish.garresori@sus.no
Contact Person Name
Herish Garresori
Contact Person Email
herish.garresori@sus.no
Site Name
St. Olavs Hospital HF
Department Name
Medical oncology
Principal Investigator Name
Eva Hofsli
Principal Investigator Email
eva.hofsli@ntnu.no
Contact Person Name
Eva Hofsli
Contact Person Email
eva.hofsli@ntnu.no
Site Name
Helse Bergen HF
Department Name
Medical oncology
Principal Investigator Name
Halfdan Sørbye
Principal Investigator Email
halfdan.sorbye@helse-bergen.no
Contact Person Name
Halfdan Sørbye
Contact Person Email
halfdan.sorbye@helse-bergen.no
Site Name
Oslo Universitetssykehus HF
Department Name
Avdeling publikum
Principal Investigator Name
Geir Olav Hjortland
Principal Investigator Email
goo@ous-hf.no
Contact Person Name
Geir Olav Hjortland
Contact Person Email
goo@ous-hf.no

Poland

Earliest CTIS Part Ii Submission Date
23-04-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
22
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Department of Oncology and Radiotherapy
Principal Investigator Name
Piotr Wysocki
Principal Investigator Email
pwysocki@uck.gda.pl
Contact Person Name
Piotr Wysocki
Contact Person Email
pwysocki@uck.gda.pl
Site Name
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Department of Endocrinology and Neuroendocrine Tumor
Principal Investigator Name
Beata Kos Kudla
Principal Investigator Email
beatakos@ka.onet.pl
Contact Person Name
Beata Kos Kudla
Contact Person Email
beatakos@ka.onet.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Clinical Trials Unit
Principal Investigator Name
Bozena Cybulska-Stopa
Principal Investigator Email
bozena.cybulska@dcopih.pl
Contact Person Name
Bozena Cybulska-Stopa
Contact Person Email
bozena.cybulska@dcopih.pl

Sponsor

Primary sponsor

Full Name
Boehringer Ingelheim International GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
IQVIA Limited
Responsibilities
Study start-up (sponsorDuties codes: 1, 12, 15); contact: josephine.kench@iqvia.com

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1, 12, 15; value: Study start-up","organisation_type":"Pharmaceutical company"}

Co-sponsors

  • Boehringer Ingelheim Espana S.A.

Investigational products

Investigational Product Name
BI 764532
Active Substance
IGG-LIKE T CELL ENGAGER BINDING TO DLL3 AND CD3
Modality
Bispecific antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
prodAuthStatus:1
Orphan Designation
Yes
Investigational Product Name
Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Active Substance
Carboplatin
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
prodAuthStatus:2
Maximum Dose
maxDailyDoseAmount: 750 mg (doseUom: mg); maxTotalDoseAmount: 3750 mg
Investigational Product Name
Etoposid Hikma 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Active Substance
Etoposide
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
prodAuthStatus:2
Maximum Dose
maxDailyDoseAmount: 100 mg/m2 (doseUom: mg/m2); maxTotalDoseAmount: 1500 mg/m2
Investigational Product Name
Avtozma 20 mg/mL concentrate for solution for infusion.
Active Substance
Tocilizumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
prodAuthStatus:2
Maximum Dose
maxDailyDoseAmount: 2400 mg; maxTotalDoseAmount: 3200 mg
Combination Treatment
Yes

Related trials

Other published trials that may interest you.