Phase
Condition
All Solid Tumors
Treatment
Zongertinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
inclusion criteria:
Signed and dated written informed consent in accordance with International Councilfor Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior toadmission to the trial.
Patients ≥18 years old or over the legal age of consent in countries where that isgreater than 18 years at the time of signature of the Informed consent form (ICF).
Documented (previously established by local testing) Human epidermal growth factorreceptor 2 (HER2) status of:
HER2 amplification
Known activating HER2 mutations
Availability and willingness to provide a sample of archival formalin-fixed paraffinembedded (FFPE) tumour tissue material
Patient with histologically or cytologically confirmed locally advanced unresectableor metastatic solid tumour who has had at least one prior line of therapy formetastatic disease. In the opinion of the Investigator, patients must be unlikely totolerate or derive clinically meaningful benefit from further standard of caretherapy known to prolong survival.
Further inclusion criteria apply.
Exclusion
exclusion criteria:
Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC)
Previous or concomitant malignancies other than the 1 treated in this trial withinthe previous 3 years except:
effectively treated non-melanoma skin cancers
effectively treated carcinoma in situ of the cervix
effectively treated ductal carcinoma in situ of the breast
localised prostate cancer on watchful waiting or active surveillance
other effectively treated malignancy that is considered cured by localtreatment.
Patients who must or wish to continue the intake of restricted medications or anydrug considered likely to interfere with the safe conduct of the trial
Not completely recovered from major surgery (major according to the investigator'sassessment) performed prior to screening or planned within 6 months after screening,e.g. hip replacement Further exclusion criteria apply.
Study Design
Connect with a study center
Macquarie University
Macquarie Park, New South Wales 2109
AustraliaActive - Recruiting
Macquarie University
Macquarie University, New South Wales 2113
AustraliaSite Not Available
GenesisCare North Shore
St Leonards, New South Wales 2065
AustraliaActive - Recruiting
Northern Cancer Institute
St Leonards, New South Wales 2065
AustraliaSite Not Available
Macquarie University
Macquarie Park 8347858, New South Wales 2155400 2109
AustraliaSite Not Available
GenesisCare North Shore
St Leonards 8029783, New South Wales 2155400 2065
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaActive - Recruiting
Princess Alexandra Hospital
Wooloongabba, Queensland 4102
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba 6943568, Queensland 2152274 4102
AustraliaSite Not Available
St John of God Subiaco Hospital
Subiaco, Western Australia 6008
AustraliaActive - Recruiting
St John of God Subiaco Hospital
Subiaco 2060886, Western Australia 2058645 6008
AustraliaSite Not Available
Cancer Research South Australia
Adelaide,
AustraliaSite Not Available
Cancer Research South Australia
Adelaide 2078025,
AustraliaSite Not Available
Cliniques Universitaires Saint-Luc
Brussels, 1200
BelgiumActive - Recruiting
Cliniques Universitaires Saint-Luc
Brussels 2800866, 1200
BelgiumSite Not Available
Brussels - UNIV Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc
Bruxelles, 1200
BelgiumActive - Recruiting
Edegem - UNIV UZ Antwerpen
Edegem, 2650
BelgiumActive - Recruiting
Universitair Ziekenhuis Antwerpen - UZA
Edegem, 2650
BelgiumSite Not Available
Edegem - UNIV UZ Antwerpen
Edegem 2799007, 2650
BelgiumSite Not Available
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
Cross Cancer Institute (University of Alberta)
Edmonton, Alberta T6G 1Z2
CanadaActive - Recruiting
Cross Cancer Institute (University of Alberta)
Edmonton 5946768, Alberta 5883102 T6G 1Z2
CanadaSite Not Available
BC Cancer Agency - Vancouver
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
BC Cancer Agency - Vancouver
Vancouver 6173331, British Columbia 5909050 V5Z 4E6
CanadaSite Not Available
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Princess Margaret Cancer Centre
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaSite Not Available
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec H2X 0A9
CanadaSite Not Available
Hopital Notre-Dame du CHUM
Montreal, Quebec H2X 0C1
CanadaSite Not Available
McGill University Health Centre (MUHC)
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal 6077243, Quebec 6115047 H2X 0A9
CanadaSite Not Available
McGill University Health Centre (MUHC)
Montreal 6077243, Quebec 6115047 H4A 3J1
CanadaSite Not Available
Peking University First Hospital
Beijing, 100034
ChinaSite Not Available
Peking University First Hospital
Beijing 1816670, 100034
ChinaSite Not Available
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016
ChinaSite Not Available
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou 1808926, 310016
ChinaSite Not Available
Anhui Provincial Cancer Hospital
Hefei, 230001
ChinaSite Not Available
Anhui Provincial Cancer Hospital
Hefei 1808722, 230001
ChinaSite Not Available
Anhui Provincial Hospital
Hefei 1808722, 230001
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
ChinaActive - Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang 1800163, 330006
ChinaSite Not Available
Shanghai East Hospital
Shanghai, 200120
ChinaActive - Recruiting
Shanghai GoBroad Cancer Hospital
Shanghai, 200131
ChinaSite Not Available
Shanghai East Hospital
Shanghai 1796236, 200120
ChinaActive - Recruiting
Shanghai GoBroad Cancer Hospital
Shanghai 1796236, 200131
ChinaSite Not Available
Wuhan Union Hospital
Wuhan, 430022
ChinaSite Not Available
Wuhan Union Hospital
Wuhan 1791247, 430022
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, 450008
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou 1784658, 450008
ChinaSite Not Available
INS Bergonie
Bordeaux, 33000
FranceActive - Recruiting
Institut Bergonié
Bordeaux, 33000
FranceActive - Recruiting
INS Bergonie
Bordeaux 3031582, 33000
FranceSite Not Available
CTR Georges-François Leclerc
Dijon, 21079
FranceActive - Recruiting
Centre Georges-François Leclerc
Dijon, 21079
FranceActive - Recruiting
CTR Georges-François Leclerc
Dijon 3021372, 21079
FranceSite Not Available
CTR Leon Berard
Lyon, 69373
FranceSite Not Available
CTR Leon Berard
Lyon 2996944, 69373
FranceSite Not Available
HOP Timone
Marseille, 13385
FranceSite Not Available
HOP Timone
Marseille 2995469, 13005
FranceSite Not Available
HOP la Milétrie
Poitiers, 86000
FranceActive - Recruiting
Hôpital de la Milétrie - CHU de Poitiers
Poitiers, 86000
FranceSite Not Available
HOP la Milétrie
Poitiers 2986495, 86000
FranceSite Not Available
INS Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Institut Gustave Roussy
Villejuif, 94805
FranceActive - Recruiting
INS Gustave Roussy
Villejuif 2968705, 94805
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif 2968705, 94805
FranceSite Not Available
Justus-Liebig Universität Gießen
Giessen, 35392
GermanyActive - Recruiting
Justus-Liebig Universität Gießen
Giessen 2920512, 35392
GermanySite Not Available
Justus-Liebig Universität Gießen
Gießen, 35392
GermanySite Not Available
Universitätsklinikum Gießen
Gießen, 35392
GermanyActive - Recruiting
Asklepios Klinik Altona
Hamburg, 22763
GermanyActive - Recruiting
Asklepios Kliniken GmbH & Co. KGaA
Hamburg, 22763
GermanyActive - Recruiting
Asklepios Kliniken GmbH & Co. KGaA
Hamburg 2911298, 22763
GermanySite Not Available
Universität Leipzig
Leipzig, 04103
GermanyActive - Recruiting
Universitätsklinikum Leipzig
Leipzig, 04103
GermanySite Not Available
Universität Leipzig
Leipzig 2879139, 04103
GermanySite Not Available
Universitätsklinikum Mannheim
Mannheim, 68167
GermanySuspended
Universitätsklinikum Mannheim GmbH
Mannheim, 68167
GermanyCompleted
Universitätsklinikum Mannheim GmbH
Mannheim 2873891, 68167
GermanySite Not Available
Klinikum rechts der Isar der Technischen Universität München
München, 81675
GermanySite Not Available
Klinikum rechts der Isar der Technischen Universität München
München 2867711, 81675
GermanySite Not Available
Az. Ospedaliera Umberto I di Ancona
Ancona, 60020
ItalySuspended
Az. Ospedaliere Umberto I di Ancona
Ancona, 60020
ItalyActive - Recruiting
Az. Ospedaliere Umberto I di Ancona
Ancona 3183089, 60020
ItalySite Not Available
Centro di riferimento Oncologico
Aviano (PN), 33081
ItalySite Not Available
Istituto Scientifico Romagnolo
Meldola (FC), 47014
ItalyActive - Recruiting
Istituto Scientifico Romagnolo
Meldola (FC) 3173635, 47014
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
ItalyActive - Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan 6951411, 20162
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda
Milano, 20162
ItalySite Not Available
Ospedale Niguarda Ca' Granda
Milano, 20162
ItalySuspended
AOU Università degli Studi della Campania Luigi Vanvitelli
Naples, 80131
ItalyActive - Recruiting
AOU Università degli Studi della Campania Luigi Vanvitelli
Napoli, 80131
ItalySite Not Available
AOU Università degli Studi della Campania Luigi Vanvitelli
Napoli 9031661, 80131
ItalySite Not Available
Fondazione Policlinico Universitario Campus Bio-medico
Rome, 00128
ItalySite Not Available
Aichi Cancer Center Hospital
Aichi, Nagoya, 464-8681
JapanActive - Recruiting
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
JapanActive - Recruiting
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
JapanSite Not Available
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
JapanSite Not Available
Hokkaido University Hospital
Hokkaido, Sapporo 2128295, 060-8648
JapanSite Not Available
Okayama University Hospital
Okayama, Okayama, 700-8558
JapanSite Not Available
Osaka International Cancer Institute
Osaka, 541-8567
JapanSite Not Available
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
JapanActive - Recruiting
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777
JapanActive - Recruiting
Shizuoka Cancer Center
Shizuoka, Sunto-gun 1851717, 411-8777
JapanSite Not Available
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
JapanActive - Recruiting
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
JapanActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 135-710
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital
Seoul, 03722
Korea, Republic ofActive - Recruiting
Nederlands Kanker Instituut
Amsterdam, 1066 CX
NetherlandsActive - Recruiting
Nederlands Kanker Instituut
Amsterdam 2759794, 1066 CX
NetherlandsSite Not Available
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GL
NetherlandsActive - Recruiting
Radboudumc
Nijmegen, 6525 GA
NetherlandsActive - Recruiting
Radboud Universitair Medisch Centrum
Nijmegen 2750053, 6525 GL
NetherlandsSite Not Available
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, N-0379
NorwayActive - Recruiting
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo 3143244, N-0379
NorwaySite Not Available
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935
Puerto RicoActive - Recruiting
Pan American Center for Oncology Trials, LLC
Rio Piedras 4829037, 00935
Puerto RicoSite Not Available
National Cancer Centre Singapore
Singapore, 168583
SingaporeSite Not Available
National Cancer Centre Singapore
Singapore 1880252, 168583
SingaporeSite Not Available
Asan Medical Center
Seoul, 05505
South KoreaActive - Recruiting
Samsung Medical Center
Seoul, 135-710
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul, 03080
South KoreaActive - Recruiting
Severance Hospital
Seoul, 03722
South KoreaActive - Recruiting
Asan Medical Center
Seoul 1835848, 05505
South KoreaActive - Recruiting
Samsung Medical Center
Seoul 1835848, 135-710
South KoreaSite Not Available
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaActive - Recruiting
Severance Hospital
Seoul 1835848, 03722
South KoreaActive - Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
SpainActive - Recruiting
Hospital A Coruña
A Coruña, 15006
SpainActive - Recruiting
Hospital Universitario A Coruña
A Coruña, 15006
SpainSite Not Available
Complejo Hospitalario Universitario A Coruña
A Coruña 3119841, 15006
SpainSite Not Available
Hospital A Coruña
A Coruña 3119841, 15006
SpainActive - Recruiting
Hospital Universitari Vall D Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Vall d'Hebron-Barcelona-47683
Barcelona, 08035
SpainSite Not Available
Hospital del Mar
Barcelona, 08003
SpainActive - Recruiting
Hospital Universitari Vall D Hebron
Barcelona 3128760, 08035
SpainSite Not Available
Hospital Vall d'Hebron
Barcelona 3128760, 08035
SpainActive - Recruiting
Hospital del Mar
Barcelona 3128760, 08003
SpainActive - Recruiting
Clínica Universidad de Navarra - Madrid
Madrid, 28027
SpainActive - Recruiting
Hospital Clínico San Carlos
Madrid, 28040
SpainActive - Recruiting
Clínica Universidad de Navarra - Madrid
Madrid 3117735, 28027
SpainSite Not Available
Hospital Clínico San Carlos
Madrid 3117735, 28040
SpainActive - Recruiting
Clínica Universidad de Navarra
Pamplona, 31008
SpainActive - Recruiting
Clínica Universidad de Navarra
Pamplona 3114472, 31008
SpainSite Not Available
Hospital Universitario Virgen del Rocío
Sevilla, 41013
SpainSite Not Available
Hospital Virgen del Rocío
Sevilla, 41013
SpainActive - Recruiting
Hospital Virgen del Rocío
Seville, 41013
SpainActive - Recruiting
Hospital Virgen del Rocío
Seville 2510911, 41013
SpainSite Not Available
Hospital Clinico De Valencia (INCLIVA)
Valencia, 46010
SpainSite Not Available
Ninewells Hospital & Medical School
Dundee, DD1 9SY
United KingdomSite Not Available
Ninewells Hospital & Medical School
Dundee 2650752, DD1 9SY
United KingdomSite Not Available
The Christie
Manchester, M20 4BX
United KingdomSite Not Available
The Christie Hospital
Manchester, M20 4BX
United KingdomSite Not Available
The Christie
Manchester 2643123, M20 4BX
United KingdomSite Not Available
Alaska Oncology and Hematology, LLC
Anchorage, Alaska 99508
United StatesActive - Recruiting
Alaska Oncology and Hematology, LLC
Anchorage 5879400, Alaska 5879092 99508
United StatesSite Not Available
University of Arizona Comprehensive Cancer Center
Phoenix, Arizona 85021
United StatesSite Not Available
University of Arizona Comprehensive Cancer Center
Tucson, Arizona 85719
United StatesSite Not Available
University of Arizona Comprehensive Cancer Center
Tucson 5318313, Arizona 5551752 85719
United StatesSite Not Available
Precision Next Gen Oncology
Beverly Hills, California 90212
United StatesSite Not Available
Precision NextGen Oncology
Beverly Hills, California 90212
United StatesActive - Recruiting
Scripps Cancer Center Torrey Pines
La Jolla, California 92037
United StatesSite Not Available
Scripps Health
La Jolla, California 92037
United StatesSite Not Available
University of California Los Angeles
Los Angeles, California 90095
United StatesSite Not Available
Valkyrie Clinical Trials
Los Angeles, California 90067
United StatesActive - Recruiting
Precision NextGen Oncology
Beverly Hills 5328041, California 5332921 90212
United StatesSite Not Available
Scripps Cancer Center Torrey Pines
La Jolla 5363943, California 5332921 92037
United StatesSite Not Available
Valkyrie Clinical Trials
Los Angeles 5368361, California 5332921 90067
United StatesSite Not Available
Yale University
New Haven, Connecticut 06520
United StatesSite Not Available
Yale University School of Medicine
New Haven, Connecticut 06511
United StatesActive - Recruiting
Yale University School of Medicine
New Haven 4839366, Connecticut 4831725 06511
United StatesSite Not Available
BRCR Global
Tamarac, Florida 33321
United StatesActive - Recruiting
BRCR Global
Tamarac 4174738, Florida 4155751 33321
United StatesSite Not Available
Illinois Cancer Specialists
Arlington Heights, Illinois 60005
United StatesSite Not Available
Illinois Cancer Specialists
Niles, Illinois 60005
United StatesSite Not Available
Illinois Cancer Specialists
Arlington Heights 4883555, Illinois 4896861 60005
United StatesSite Not Available
Community MD Anderson Cancer Center - East Medical Oncology
Indianapolis, Indiana 46219
United StatesActive - Recruiting
Community MD Anderson Cancer Center - East Medical Oncology
Indianapolis 4259418, Indiana 4921868 46219
United StatesSite Not Available
Maryland Oncology Hematology, Columbia
Columbia, Maryland 21044
United StatesSite Not Available
Maryland Oncology Hematology, P.A
Rockville, Maryland 20850
United StatesSite Not Available
Maryland Oncology Hematology, PA
Rockville, Maryland 20850
United StatesSite Not Available
Maryland Oncology Hematology, Columbia
Columbia 4352053, Maryland 4361885 21044
United StatesSite Not Available
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center Basking Ridge
New York, New York 10065
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Mount Sinai School of Medicine
New York, New York 10029
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
Memorial Sloan-Kettering Cancer Center
New York 5128581, New York 5128638 10065
United StatesSite Not Available
Taylor Cancer Research Center
Maumee, Ohio 43537
United StatesSite Not Available
Taylor Cancer Research Center
Maumee 5162137, Ohio 5165418 43537
United StatesSite Not Available
Alliance Cancer Specialists, PC
Horsham, Pennsylvania 19044
United StatesSite Not Available
Alliance Cancer Specialists, PC, Wynnewood
Wynnewood, Pennsylvania 19096
United StatesSite Not Available
Alliance Cancer Specialists, PC, Wynnewood
Wynnewood 5220230, Pennsylvania 6254927 19096
United StatesSite Not Available
Mary Crowley Cancer Research
Dallas, Texas 75230
United StatesSite Not Available
Mary Crowley Cancer Research Center
Dallas, Texas 75230
United StatesSite Not Available
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas 75230
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Texas Oncology - Plano West
Plano, Texas 75093
United StatesSite Not Available
Sarah Cannon Research Institute at Mary Crowley
Dallas 4684888, Texas 4736286 75230
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesSite Not Available
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United StatesActive - Recruiting
VCU Health Community Memorial Hospital
South Hill, Virginia 23970
United StatesSite Not Available
Virginia Cancer Specialists, PC
Fairfax 4758023, Virginia 6254928 22031
United StatesSite Not Available

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