Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
NCT ID: NCT06324357
Last Updated: 2025-11-12
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
PHASE1/PHASE2
582 participants
INTERVENTIONAL
2024-06-03
2029-09-28
Brief Summary
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In this study, participants receive treatment in cycles. Study participants are treated with zongertinib alone or in combination with other treatments. This study has 2 parts. In Part 1, participants in different groups receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group.
During the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with other treatments. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase Ib - Cohort A: zongertinib + Trastuzumab emtansine
Dose escalation (Phase Ib)
Zongertinib
Zongertinib
Trastuzumab emtansine
Trastuzumab emtansine
Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecan
Dose escalation (Phase Ib)
Zongertinib
Zongertinib
Trastuzumab deruxtecan
Trastuzumab deruxtecan
Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecan
Dose escalation (Phase Ib)
Zongertinib
Zongertinib
Trastuzumab deruxtecan
Trastuzumab deruxtecan
Phase II - Cohort D: zongertinib + Trastuzumab emtansine
Dose optimization (Phase II).
Zongertinib
Zongertinib
Trastuzumab emtansine
Trastuzumab emtansine
Phase II - Cohort E: zongertinib + Trastuzumab deruxtecan
Dose optimization (Phase II).
Zongertinib
Zongertinib
Trastuzumab deruxtecan
Trastuzumab deruxtecan
Phase II - Cohort F: zongertinib + Trastuzumab deruxtecan
Dose optimization (Phase II).
Zongertinib
Zongertinib
Trastuzumab deruxtecan
Trastuzumab deruxtecan
Phase Ib - Cohort G: zongertinib + trastuzumab + capecitabine
Dose escalation (Phase Ib)
Zongertinib
Zongertinib
Trastuzumab
Herceptin®
Capecitabine
Xeloda®
Phase Ib - Cohort K: zongertinib + trastuzumab
Dose escalation (Phase Ib)
Zongertinib
Zongertinib
Trastuzumab
Herceptin®
Phase II - Cohort H: zongertinib + trastuzumab + capecitabine
Dose optimization (Phase II).
Zongertinib
Zongertinib
Trastuzumab
Herceptin®
Capecitabine
Xeloda®
Phase II - Cohort I: zongertinib
Dose optimization (Phase II).
Zongertinib
Zongertinib
Phase II - Cohort J: zongertinib + trastuzumab
Dose optimization (Phase II).
Zongertinib
Zongertinib
Trastuzumab
Herceptin®
Phase II - Cohort I-ext: zongertinib
Extension Phase II
Zongertinib
Zongertinib
Phase II - Cohort J-ext: zongertinib + trastuzumab
Extension Phase II
Zongertinib
Zongertinib
Trastuzumab
Herceptin®
Interventions
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Zongertinib
Zongertinib
Trastuzumab deruxtecan
Trastuzumab deruxtecan
Trastuzumab emtansine
Trastuzumab emtansine
Trastuzumab
Herceptin®
Capecitabine
Xeloda®
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF.
* Documented Human epidermal growth factor receptor 2 overexpressing and/or amplified (HER2+), metastatic breast cancer (mBC) or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma (mGEAC).
* For dose optimization (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible, collected through archival tissue.
* Documented investigator assessed progression after HER2-directed treatment (including treatment with trastuzumab deruxtecan (T-DXd) for non-T-DXd combination cohorts) for unresectable locally advanced or metastatic disease.
* Recovered from any previous therapy-related toxicity to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at start of treatment (except for alopecia, stable sensory neuropathy, and hypothyroidism (patients on thyroid replacement therapy) which must be ≤ CTCAE Grade 2).
* Presence of at least one measurable lesion according to Response evaluation criteria in solid tumors (RECIST) 1.1, as determined by the local site investigator/radiology assessment.
Exclusion Criteria
* effectively treated non-melanoma skin cancers
* effectively treated carcinoma in situ of the cervix
* effectively treated ductal carcinoma in situ
* other effectively treated malignancy that is considered cured by local treatment
* History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of ≥ III or IV, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the investigator. Myocardial infarction (or troponin levels consistent with myocardial infarction within 28 days of randomization), stroke, or pulmonary embolism within 6 months prior to randomization.
* Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting electrocardiograms, e.g. complete left bundle branch block, third degree heart block.
* Mean resting corrected QT interval (QT interval corrected for heart rate by Fridericia´s formula (QTcF)) \>470 msec.
* Any factors that increase the risk of QT interval corrected for heart rate (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, personal or family history of long QT syndrome or unexplained sudden death under 40 years-of-age.
* Ejection fraction \<50% or the lower limit of normal of the institutional standard within 28 days prior to randomization.
* Women who are pregnant or nursing or who plan to become pregnant or nurse during the trial or within 7 months after the last dose of trial treatment with T-DXd, T-DM1, trastuzumab or capecitabine and trastuzumab.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic-Arizona
Phoenix, Arizona, United States
The Oncology Institute of Hope and Innovation
Cerritos, California, United States
Ellison Medical Institute
Los Angeles, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
University of California Irvine
Orange, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Mayo Clinic - Florida
Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Community Health Network
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Baptist Cancer Center - Memphis
Memphis, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Tennessee Oncology, Pllc
Nashville, Tennessee, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Edegem - UNIV UZ Antwerpen
Edegem, , Belgium
UZ Leuven
Leuven, , Belgium
Hôpital Vivalia De Libramont
Libramont-Chevigny, , Belgium
Centre Hospitalier Universitaire de Liège
Liège, , Belgium
CHU UCL Namur
Namur, , Belgium
Jilin Province Cancer Hospital
Changchun, , China
The First Hospital of Jilin University
Changchun, , China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Jiangsu Province Hospital
Nanjing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Tianjin Cancer Hospital
Tianjin, , China
Henan Cancer Hospital
Zhengzhou, , China
INS Bergonie
Bordeaux, , France
CTR François Baclesse
Caen, , France
CTR Georges-François Leclerc
Dijon, , France
CTR Leon Berard
Lyon, , France
INS Paoli-Calmettes
Marseille, , France
HOP Tenon
Paris, , France
CTR Eugène Marquis
Rennes, , France
Institut de Cancérologie de l'Ouest
Saint-Herblain, , France
Institut de Cancérologie de Strasbourg
Strasbourg, , France
INS Claudius Regaud IUCT-Oncopole
Toulouse, , France
INS Gustave Roussy
Villejuif, , France
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Evang. Kliniken Essen-Mitte gGmbh
Essen, , Germany
Asklepios Kliniken GmbH & Co. KGaA
Hamburg, , Germany
Universitätsklinikum Mannheim GmbH
Mannheim, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Istituto Di Candiolo
Candiolo (TO), , Italy
Az.Osp. Universitaria "Ospedali Riuniti"
Foggia, , Italy
Istituto Scientifico Romagnolo
Meldola (FC), , Italy
Ospedale San Raffaele S.r.l.
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Humanitas Istituto Clinico Catanese S.p.A.
Misterbianco (CT), , Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Napoli, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Aichi Cancer Center Hospital
Aichi, Nagoya, , Japan
Hakuaikai Sagara Hospital
Kagoshima, , Japan
Tokai University Hospital
Kanagawa, Isehara, , Japan
Kanagawa Cancer Center
Kanagawa, Yokohama, , Japan
National Cancer Center Hospital East
Kashiwa-shi, , Japan
Kyoto University Hospital
Kyoto, Kyoto, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, , Japan
CHA Bundang Medical Center
Seongnam-si, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital Teresa Herrera
A Coruña, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Vall D Hebron
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Clínica Universidad de Navarra - Madrid
Madrid, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
CIO Clara Campal
Madrid, , Spain
Hospital Universitario Virgen De La Macarena
Seville, , Spain
Instituto Valenciano de Oncología
Valencia, , Spain
Velindre Cancer Centre
Cardiff, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
University College Hospital
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
The Christie
Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Boehringer Ingelheim
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References
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Hurvitz S, Simonelli M, Yarza R, Berz D, Kitano S, Del Conte G, Acosta Eyzaguirre D, Doger de Speville Uribe BG, Maier D, Erzen D, Aykut Yazgili S, Curigliano G, Deng T, Yan M, Zhang Q, Wang X, Nakayama I, Shitara K. Beamion BCGC-1: phase Ib/II trial of zongertinib for advanced HER2-positive breast or gastroesophageal cancers. Future Oncol. 2025 Oct 17:1-9. doi: 10.1080/14796694.2025.2569553. Online ahead of print.
Related Links
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Related Info
Other Identifiers
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1479-0012
Identifier Type: -
Identifier Source: org_study_id