Clinical trial • Phase II • Oncology

ZONGERTINIB for HER2-mutated or HER2-overexpressing/amplified solid tumours

Phase II trial of ZONGERTINIB for HER2-mutated or HER2-overexpressing/amplified solid tumours. open-label, none/not specified-controlled. 92 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
HER2-mutated or HER2-overexpressing/amplified solid tumours
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
23-05-2024
First CTIS Authorization Date
09-09-2024

Trial design

open-label, none/not specified-controlled Phase II trial in Italy, Netherlands, Norway and others.

Open Label
Yes
Comparator
None/Not specified
Biomarker Stratified
True, biomarker: HER2 status (strata: HER2 overexpression/amplification; known activating HER2 mutations)
Target Sample Size
92

Eligibility

Recruits 92 No vulnerable populations selected. Only adults (Patients ≥18 years or the legal age of consent in relevant countries) are eligible. Informed consent must be signed and dated by the participant in accordance with ICH-GCP and local legislation prior to inclusion. No assent/parental consent procedures are described for minors..

Vulnerable Population
No vulnerable populations selected. Only adults (Patients ≥18 years or the legal age of consent in relevant countries) are eligible. Informed consent must be signed and dated by the participant in accordance with ICH-GCP and local legislation prior to inclusion. No assent/parental consent procedures are described for minors.

Inclusion criteria

  • {"criterion_text":"- 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial."}
  • {"criterion_text":"- 2. Patients ≥18 years old or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF."}
  • {"criterion_text":"- 3. Documented (previously established by local testing) HER2 status of: a. HER2 overexpression/amplification b. Known activating HER2 mutations"}
  • {"criterion_text":"- 4. Availability and willingness to provide a sample of archival formalin-fixed paraffin embedded (FFPE) tumour tissue material"}
  • {"criterion_text":"- 5. Patient atteint d’une tumeur solide localement avancée, non résécable ou métastatique, confirmée histologiquement ou cytologiquement, et qui a déjà reçu au moins une ligne de traitement pour une maladie métastatique. Le patient doit présenter une progression documentée de la maladie ou une récidive pendant ou après la dernière ligne de traitement. Selon l’avis de l’investigateur, les patients doivent être peu susceptibles de tolérer ou de retirer un bénéfice cliniquement significatif d’une autre thérapie standard, connue pour prolonger la survie."}
  • {"criterion_text":"- Further inclusion criteria apply."}

Exclusion criteria

  • {"criterion_text":"- 1. Diagnosis of HER2 mutant NSCLC (except where there is co-existing presence of HER2 overexpression / amplification)."}
  • {"criterion_text":"- 2. Previous or concomitant malignancies other than the 1 treated in this trial within the previous 3 years except: i. effectively treated non-melanoma skin cancers ii. effectively treated carcinoma in situ of the cervix iii. effectively treated ductal carcinoma in situ of the breast iv.localised prostate cancer on watchful waiting or active surveillance v.other effectively treated malignancy that is considered cured by local treatment."}
  • {"criterion_text":"- 3. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial"}
  • {"criterion_text":"- 4. Not completely recovered from major surgery (major according to the investigator’s assessment) performed prior to screening or planned within 6 months after screening, e.g. hip replacement"}
  • {"criterion_text":"- Further exclusion criteria apply."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of patients with objective response (OR)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Duration of objective response (DOR)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Progression free survival (PFS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Disease control (DC)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Occurrence of treatment-emergent adverse events (AEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline to Week 48 or PD by central independent review, if earlier, in the European Organisation for Research and Treatment of Cancer, (EORTC QLQ-C30)","definition_or_measurement_approach":"Change from baseline to Week 48 or to progressive disease (PD) as assessed by central independent review using the EORTC QLQ-C30 questionnaire."}

Recruitment

Planned Sample Size
92
Recruitment Window Months
49
Consent Approach
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Participants must be ≥18 years old or of legal consenting age in their country. Subject information and informed consent forms are provided in multiple country/language-specific versions (examples in the dossier include English, Dutch, French, Spanish, Italian, German, Norwegian and language-specific ICF biobanking and pregnant-partner information where applicable).

Geography

Total Number Of Sites
28
Total Number Of Participants
108

Italy

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
11-09-2024
Processing Time Days
5
Number Of Sites
4
Number Of Participants
17

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Niguarda Cancer Center
Contact Person Name
Salvatore Siena
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Struttura Semplice Dipartimentale di Oncologia Toracica
Contact Person Name
Alessandro Bittoni
Contact Person Email
alessandro.bittoni@irst.emr.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Clinica Oncologica
Contact Person Name
Rossana Berardi
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Oncoematologia
Contact Person Name
Erika Martinelli

Netherlands

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
16-09-2024
Processing Time Days
10
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Netherlands Cancer Institute
Department Name
Nederlands Kanker Instituut
Contact Person Name
Frans Opdam
Contact Person Email
f.opdam@nki.nl
Site Name
Stichting Radboud universitair medisch centrum
Department Name
Department of Medical Oncology
Contact Person Name
I.M.E. Desar
Contact Person Email
i.desar@aig.umcn.nl

Norway

Earliest CTIS Part Ii Submission Date
16-08-2024
Latest Decision Or Authorization Date
09-09-2024
Processing Time Days
24
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Oslo University Hospital HF
Department Name
Oncology Service
Contact Person Name
Tormod Guren
Contact Person Email
uxtour@ous-hf.no

Spain

Earliest CTIS Part Ii Submission Date
29-08-2024
Latest Decision Or Authorization Date
09-09-2024
Processing Time Days
11
Number Of Sites
8
Number Of Participants
30

Sites

Site Name
Hospital Clinico San Carlos
Department Name
Oncology Service
Contact Person Name
Jorge Bartolomé
Contact Person Email
jorgebart@msn.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology Service
Contact Person Name
Ana Gil Torralvo
Contact Person Email
anagil886@gmail.com
Site Name
Clinica Universidad De Navarra
Department Name
Oncology Service
Contact Person Name
Mariano Ponz
Contact Person Email
mponz@unav.es
Site Name
Clinica Universidad De Navarra
Department Name
Oncology Service
Contact Person Name
Mariano Ponz
Contact Person Email
mponz@unav.es
Site Name
Hospital Del Mar
Department Name
Oncology service
Contact Person Name
María Martínez García
Contact Person Email
mariamartinezgarcia@hmar.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology Institute
Contact Person Name
Alberto Hernando Calvo
Contact Person Email
albertohernando@vhio.net
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology Service
Contact Person Name
Manuel Fernandez Bruno
Site Name
Clinica Universidad De Navarra
Department Name
Oncology Service
Contact Person Name
Mariano Ponz
Contact Person Email
mponz@unav.es

Belgium

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
12-09-2024
Processing Time Days
31
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Contact Person Name
Cedric Van Marcke de Lummen
Contact Person Email
cedric.vanmarcke@uclouvain.be
Site Name
Antwerp University Hospital
Department Name
Medical Oncology
Contact Person Name
Hans Prenen
Contact Person Email
Hans.Prenen@uza.be

France

Earliest CTIS Part Ii Submission Date
22-08-2024
Latest Decision Or Authorization Date
13-09-2024
Processing Time Days
22
Number Of Sites
6
Number Of Participants
16

Sites

Site Name
Centre Leon Berard
Department Name
Oncologie Médicale
Contact Person Name
Philippe Cassier
Site Name
Institut Bergonie
Department Name
Early Phase Trials and Sarcoma Units
Contact Person Name
Antoine Italiano
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Pôle Régional de Cancérologie
Contact Person Name
Sheik Emambux
Contact Person Email
sheik.emambux@chu-poitiers.fr
Site Name
Institut Gustave Roussy
Department Name
Service d’Onco-Pneumologie
Contact Person Name
David Planchard
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service d'Oncologie Multidisciplinaire et Innovation thérapeutique
Contact Person Name
Laurent Greillier
Contact Person Email
Laurent.GREILLIER@ap-hm.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Unité de phases précoces U2P
Contact Person Name
François Ghiringhelli
Contact Person Email
FGhiringhelli@cgfl.fr

Germany

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
11-09-2024
Processing Time Days
5
Number Of Sites
5
Number Of Participants
19

Sites

Site Name
Universitaet Leipzig
Department Name
Universitäres Krebszentrum Leipzig (UCCL)
Contact Person Name
Florian Lordick
Site Name
Universitat Heidelberg
Department Name
Universitäts-Frauenklinik - Gynäkologische Onkologie
Contact Person Name
Frederik Marmé
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Universitätsklinikum Gießen und Marburg GmbH
Contact Person Name
Thomas Wehler
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Klinik und Poliklinik für Innere Medizin III
Contact Person Name
Sylvie Lorenzen
Contact Person Email
Sylvie.Lorenzen@mri.tum.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Asklepios Tumorzentrum Hamburg
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com

Sponsor

Primary sponsor

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

Co-sponsors

  • Boehringer Ingelheim Espana S.A.

Investigational products

Investigational Product Name
BI 1810631
Active Substance
ZONGERTINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL

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