Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
NCT ID: NCT06581432
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
430 participants
INTERVENTIONAL
2024-10-11
2028-12-29
Brief Summary
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Participants are put into 13 groups based on the type of advanced cancer and the type of HER2 alterations they have. All participants take one dose of zongertinib each day. Participants can continue the treatment as long as they benefit from it and can tolerate it.
Participants visit the study site regularly. During many of the visits, the doctors check the size of the tumour and whether it has spread to other parts of the body. During all the visits, the doctors check participants' health and take note of any unwanted effects.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zongertinib treatment
Zongertinib
Zongertinib
Interventions
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Zongertinib
Zongertinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Informed consent form (ICF).
* Documented (previously established by local testing) Human epidermal growth factor receptor 2 (HER2) status of:
* HER2 overexpression/amplification
* Known activating HER2 mutations
* Availability and willingness to provide a sample of archival formalin-fixed paraffin embedded (FFPE) tumour tissue material
* Patient with histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumour who has had at least one prior line of therapy for metastatic disease. In the opinion of the Investigator, patients must be unlikely to tolerate or derive clinically meaningful benefit from further standard of care therapy known to prolong survival.
Exclusion Criteria
* Previous or concomitant malignancies other than the 1 treated in this trial within the 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 local treatment.
* 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
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Alaska Oncology and Hematology, LLC
Anchorage, Alaska, United States
University of Arizona Comprehensive Cancer Center
Tucson, Arizona, United States
Precision NextGen Oncology
Beverly Hills, California, United States
Scripps Cancer Center Torrey Pines
La Jolla, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
BRCR Global
Tamarac, Florida, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Community MD Anderson Cancer Center - East Medical Oncology
Indianapolis, Indiana, United States
Maryland Oncology Hematology, Columbia
Columbia, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Taylor Cancer Research Center
Maumee, Ohio, United States
Alliance Cancer Specialists, PC, Wynnewood
Wynnewood, Pennsylvania, United States
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Macquarie University
Macquarie Park, New South Wales, Australia
GenesisCare North Shore
St Leonards, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia
Cancer Research South Australia
Adelaide, , Australia
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Edegem - UNIV UZ Antwerpen
Edegem, , Belgium
Cross Cancer Institute (University of Alberta)
Edmonton, Alberta, Canada
BC Cancer Agency - Vancouver
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Peking University First Hospital
Beijing, , China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, , China
Anhui Provincial Cancer Hospital
Hefei, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Shanghai East Hospital
Shanghai, , China
Shanghai GoBroad Cancer Hospital
Shanghai, , China
Wuhan Union Hospital
Wuhan, , China
Henan Cancer Hospital
Zhengzhou, , China
INS Bergonie
Bordeaux, , France
CTR Georges-François Leclerc
Dijon, , France
CTR Leon Berard
Lyon, , France
HOP Timone
Marseille, , France
HOP la Milétrie
Poitiers, , France
INS Gustave Roussy
Villejuif, , France
Justus-Liebig Universität Gießen
Giessen, , Germany
Asklepios Kliniken GmbH & Co. KGaA
Hamburg, , Germany
Universität Leipzig
Leipzig, , Germany
Universitätsklinikum Mannheim GmbH
Mannheim, , Germany
Klinikum rechts der Isar der Technischen Universität München
München, , Germany
Az. Ospedaliere Umberto I di Ancona
Ancona, , Italy
Istituto Scientifico Romagnolo
Meldola (FC), , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
AOU Università degli Studi della Campania Luigi Vanvitelli
Napoli, , Italy
Aichi Cancer Center Hospital
Aichi, Nagoya, , Japan
National Cancer Center Hospital East
Chiba, Kashiwa, , Japan
Kyushu University Hospital
Fukuoka, Fukuoka, , Japan
Hokkaido University Hospital
Hokkaido, Sapporo, , Japan
Okayama University Hospital
Okayama, Okayama, , Japan
Osaka International Cancer Institute
Osaka, Osaka, , Japan
Shizuoka Cancer Center
Shizuoka, Sunto-gun, , Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, , Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, , Japan
Nederlands Kanker Instituut
Amsterdam, , Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, , Netherlands
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, , Norway
Pan American Center for Oncology Trials, LLC
Rio Piedras, , Puerto Rico
National Cancer Centre Singapore
Singapore, , Singapore
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Vall D Hebron
Barcelona, , Spain
Clínica Universidad de Navarra - Madrid
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Clínica Universidad de Navarra
Pamplona, , Spain
Hospital Virgen del Rocío
Seville, , Spain
Ninewells Hospital & Medical School
Dundee, , United Kingdom
The Christie
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Other Identifiers
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2023-510429-14-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1302-3333
Identifier Type: REGISTRY
Identifier Source: secondary_id
1479-0009
Identifier Type: -
Identifier Source: org_study_id
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