Metastatic Breast CancerPhase 1/2NCT06324357
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
A Phase 1/2 study testing Zongertinib, Trastuzumab deruxtecan and Trastuzumab emtansine in people with Metastatic Breast Cancer and Metastatic Gastric Adenocarcinoma, run by Boehringer Ingelheim at 104 sites in 10 countries.
Trial summary
This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Zongertinib, Trastuzumab deruxtecan and Trastuzumab emtansine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 768 participants
- Where
- 104 sitesin 10 countries
- Study dates
- 28 Jun 2024to 8 Jan 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 informed consent form (ICF)
- Cohorts A to K and Cohort O: 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).
- Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2) overexpression/amplification according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) gastric cancer guidelines and according to the result of local testing.
- For dose optimization and justification (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible, collected through archival tissue
- History of prior treatment lines in palliative setting:
- For cohorts A, B, C, D, E, F, G, H, I, I-ext, J, J-ext, K and O documented investigator assessed progression after HER2-directed treatment for unresectable locally advanced or metastatic disease (For Cohorts D, H, I (I-ext), J (J-ext) - patients must have been pretreated with trastuzumab deruxtecan (T-DXd) and have progressed or have been intolerant to previous T-DXd).
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- For cohorts L, L-ext, M and N documented progression or recurrence of disease during or following their latest line of therapy. Patients must have had at least one prior line of therapy for locally advanced unresectable disease or metastatic disease (adjuvant and neoadjuvant therapy excluded) and documented disease progression or recurrence of disease during or following their latest line of therapy. 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.
- Presence of at least one measurable lesion according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Adequate organ function based on laboratory values Further inclusion criteria apply.
Who cannot join
- Previous treatment with:
- Any small molecule HER2 inhibitor in the palliative setting in Cohorts D, E, F, H, L, L-ext, M, and N. In Cohort D allowed in up to 15 patients in each dose level (DL).
- T-DXd in Cohorts E and F. In Cohort E allowed in up to 15 patients in each DL.
- trastuzumab emtansine (T-DM1) in the palliative setting in Cohort D and H. In Cohort H allowed in up to 15 patients in each DL.
- Capecitabine in Cohort D and H. In Cohort D allowed in up to 15 patients in each DL
- Presence of uncontrolled and/or symptomatic brain metastases, or leptomeningeal disease
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- 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
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening Further exclusion criteria apply.
Trial locations and contacts
104 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
104 sites in 10 countries
United States26 sites, 26 recruiting
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
The Oncology Institute of Hope and Innovation
Cerritos, California, 90703
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
The Methodist Hospital Research Institute
Houston, Texas, 77030
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Community Health Network
Indianapolis, Indiana, 46250
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Helios CR Inc
Lakeland, Florida, 33812
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Ellison Medical Institute
Los Angeles, California, 90064
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Baptist Cancer Center - Memphis
Memphis, Tennessee, 38120
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Tennessee Oncology, Pllc
Nashville, Tennessee, 37203
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06510
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of California Irvine
Orange, California, 92868
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Sharp Memorial Hospital
San Diego, California, 92123
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
New York Cancer & Blood Specialists
Shirley, New York, 11967
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Orchard Healthcare Research Inc.- Skokie
Skokie, Illinois, 60077
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Spain14 sites, 14 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital del Mar
Barcelona, 08003
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Duran i Reynals
L'Hospitalet de Llobregat, 8906
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Clínica Universidad de Navarra - Madrid
Madrid, 28022
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Fundación Jiménez Díaz
Madrid, 28040
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Clínico San Carlos
Madrid, 28040
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
CIO Clara Campal
Madrid, 28050
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario Virgen De La Macarena
Seville, 41009
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Instituto Valenciano de Oncología
Valencia, 46009
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
France10 sites, 10 recruiting
- Recruiting
INS Bergonie
Bordeaux, 33000
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
CTR François Baclesse
Caen, 14076
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
CTR Leon Berard
Lyon, 69008
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
INS Paoli-Calmettes
Marseille, 13273
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Tenon
Paris, 75020
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
CTR Eugène Marquis
Rennes, 35042
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44800
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Institut de Cancérologie de Strasbourg
Strasbourg, 67200
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
INS Claudius Regaud IUCT-Oncopole
Toulouse, 31059
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
United Kingdom10 sites, 10 recruiting
- Recruiting
Velindre Cancer Centre
Cardiff, CF14 2TL
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
St James's University Hospital
Leeds, LS9 7TF
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Not yet recruiting
St Bartholomew's Hospital
London, EC1A 7BE
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
University College Hospital
London, NW1 2BU
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Royal Free Hospital
London, NW3 2QG
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
The Royal Marsden Hospital, Chelsea
London, SW3 6JJ
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
The Christie Hospital
Manchester, M20 4BX
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Not yet recruiting
Nottingham University Hospital
Nottingham, NG5 1PB
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
The Royal Marsden Hospital, Sutton
Sutton, SM2 5PT
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
China8 sites, 8 recruiting
- Recruiting
Jilin Province Cancer Hospital
Changchun, 130012
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Hospital of Jilin University
Changchun, 130021
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, 150081
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Jiangsu Province Hospital
Nanjing, 210029
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Tianjin Cancer Hospital
Tianjin, 300060
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, 450003
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Italy8 sites, 8 recruiting
- Recruiting
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Istituto Di Candiolo
Candiolo (TO), 10060
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Istituto Scientifico Romagnolo
Meldola (FC), 47014
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Ospedale San Raffaele S.r.l.
Milan, 20132
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Istituto Europeo di Oncologia
Milan, 20141
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Humanitas Istituto Clinico Catanese S.p.A.
Misterbianco (CT), 95045
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Naples, 80131
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Istituto Clinico Humanitas
Rozzano, 20089
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Japan8 sites, 8 recruiting
- Recruiting
Aichi Cancer Center Hospital
Aichi, Nagoya, 464-8681
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Tokai University Hospital
Isehara, 259-1193
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Hakuaikai Sagara Hospital
Kagoshima, 892-0833
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kanagawa Cancer Center
Kanagawa, Yokohama, 241-8515
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
National Cancer Center Hospital East
Kashiwa-shi, 277-8577
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kyoto University Hospital
Kyoto, 606-8507
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Osaka International Cancer Institute
Osaka, 541-8567
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
South Korea8 sites, 8 recruiting
- Recruiting
CHA Bundang Medical Center
Seongnam-si, 13496
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Seoul National University Hospital
Seoul, 03080
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Asan Medical Center
Seoul, 05505
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Korea University Anam Hospital
Seoul, 2841
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, 6273
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 6591
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Belgium6 sites, 5 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Recruiting
UZ Leuven
Leuven, 3000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Recruiting
Hôpital Vivalia De Libramont
Libramont-Chevigny, 6800
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Terminated
Centre Hospitalier Universitaire de Liège
Liège, 4000
- Recruiting
CHU UCL Namur
Namur, 5000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Germany6 sites, 6 recruiting
- Recruiting
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Erlangen
Erlangen, 91054
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Evang. Kliniken Essen-Mitte gGmbh
Essen, 45136
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Asklepios Kliniken GmbH & Co. KGaA
Hamburg, 22763
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Mannheim GmbH
Mannheim, 68167
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Ulm
Ulm, 89075
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
About this study
Official title: Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)
This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab and capecitabine, with zanidatamab, or with mFOLFOX6 (with or without trastuzumab). Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow.
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.
- Conditions
- Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, Colorectal Cancer
- Being tested
- Zongertinib, Trastuzumab deruxtecan, Trastuzumab emtansine, Trastuzumab, Capecitabine
- Medical subject headings
- Breast Neoplasms, Adenocarcinoma Of Esophagus, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZongertinibDrug
Also called BI 1810631, Hernexeos®
Zongertinib
Trastuzumab deruxtecanDrug
Also called T-DXd; Enhertu®
Trastuzumab deruxtecan
Trastuzumab emtansineDrug
Also called T-DM1; Kadcyla®
Trastuzumab emtansine
TrastuzumabDrug
Herceptin®
CapecitabineDrug
Xeloda®
mFOLFOX6Drug
mFOLFOX6
zanidatamabDrug
zanidatamab
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib - Cohort A: zongertinib + Trastuzumab emtansine | Experimental | Dose escalation (Phase Ib) Receives: Drug: Zongertinib; Drug: Trastuzumab emtansine |
| Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecan | Experimental | Dose escalation (Phase Ib) Receives: Drug: Zongertinib; Drug: Trastuzumab deruxtecan |
| Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecan | Experimental | Dose escalation (Phase Ib) Receives: Drug: Zongertinib; Drug: Trastuzumab deruxtecan |
| Phase II - Cohort D: zongertinib + Trastuzumab emtansine | Experimental | Dose optimization (Phase II). Receives: Drug: Zongertinib; Drug: Trastuzumab emtansine |
| Phase II - Cohort E: zongertinib + Trastuzumab deruxtecan | Experimental | Dose optimization (Phase II). Receives: Drug: Zongertinib; Drug: Trastuzumab deruxtecan |
| Phase II - Cohort F: zongertinib + Trastuzumab deruxtecan | Experimental | Dose optimization (Phase II). Receives: Drug: Zongertinib; Drug: Trastuzumab deruxtecan |
| Phase Ib - Cohort G: zongertinib + trastuzumab + capecitabine | Experimental | Dose escalation (Phase Ib) Receives: Drug: Zongertinib; Drug: Trastuzumab; Drug: Capecitabine |
| Phase Ib - Cohort K: zongertinib + trastuzumab | Experimental | Dose escalation (Phase Ib) Receives: Drug: Zongertinib; Drug: Trastuzumab |
| Phase II - Cohort H: zongertinib + trastuzumab + capecitabine | Experimental | Dose optimization (Phase II). Receives: Drug: Zongertinib; Drug: Trastuzumab; Drug: Capecitabine |
| Phase II - Cohort I: zongertinib | Experimental | Dose optimization (Phase II). Receives: Drug: Zongertinib |
| Phase II - Cohort J: zongertinib + trastuzumab | Experimental | Dose optimization (Phase II). Receives: Drug: Zongertinib; Drug: Trastuzumab |
| Phase II - Cohort I-ext: zongertinib | Experimental | Extension Phase II Receives: Drug: Zongertinib |
| Phase II - Cohort J-ext: zongertinib + trastuzumab | Experimental | Extension Phase II Receives: Drug: Zongertinib; Drug: Trastuzumab |
| Phase Ib - Cohort M: zongertinib + mFOLFOX6 | Experimental | Dose escalation (Phase Ib) Receives: Drug: Zongertinib; Drug: mFOLFOX6 |
| Phase Ib - Cohort N: zongertinib + trastuzumab + mFOLFOX6 | Experimental | Dose escalation (Phase Ib) Receives: Drug: Zongertinib; Drug: Trastuzumab; Drug: mFOLFOX6 |
| Phase Ib - Cohort O: zongertinib + zanidatamab | Experimental | Dose escalation (Phase Ib) - is not conducted in China or South Korea Receives: Drug: Zongertinib; Drug: zanidatamab |
| Phase II - Cohort L: zongertinib + trastuzumab | Experimental | Dose justification (Phase II) Receives: Drug: Zongertinib; Drug: Trastuzumab |
| Phase II - Cohort L-ext: zongertinib + trastuzumab | Experimental | Extension Phase II Receives: Drug: Zongertinib; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
The MTD evaluation period is defined as the first 21 days of the first treatment cycle for Cohorts A, B, C, G, K, and O. The MTD evaluation period is defined as the first 28 days after the first administration of any trial medication for Cohorts M and N.
Measured: up to 21 days
Dose optimization and justification (Phase II): Objective response (OR)
Objective response (OR) is defined as the best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, or treatment discontinuation as assessed by investigator review.
Measured: up to 50 months
Secondary outcomes (13)
Dose escalation (Phase Ib): Objective response (OR)
Measured: up to 50 months
Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) during the entire treatment period
Measured: up to 50 months
Dose escalation (Phase Ib): Maximum measured concentration of zongertinib (at steady state) (Cmax,(ss))
For cycle 2 only.
Measured: up to 2 days
Dose escalation (Phase Ib): Area under the concentration-time curve of zongertinib over the time interval from 0 to 4h at steady state (AUC0-4h,ss)
For cycle 2 only.
Measured: up to 2 days
Dose escalation (Phase Ib): Area under the concentration-time curve of zongertinib over the time interval from 0 to the last quantifiable data point at steady state (AUC0-tz,ss)
For cycle 2 only.
Measured: up to 2 days
Dose optimization and justification (Phase II): Progression-free survival (PFS)
PFS is defined as the time from treatment start until the earliest date of tumor progression according RECIST 1.1 based on investigator review or death from any cause, whichever occurs first.
Measured: up to 50 months
Dose optimization and justification (Phase II): Disease control (DC)
DC is 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 from first treatment administration until the earliest of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, or treatment discontinuation, as assessed by investigator review.
Measured: up to 50 months
Dose optimization and justification (Phase II): Occurrence of treatment-emergent AEs leading to zongertinib (BI 1810631) dose reduction during the on-treatment period
Measured: up to 50 months
Dose optimization and justification (Phase II): Maximum measured concentration (at steady state) (Cmax,(ss))
Measured: up to 50 months
Dose optimization and justification (Phase II): Area under the concentration-time curve over the time interval from 0 to the last quantifiable data point at steady state (AUC0-tz,ss)
Measured: up to 50 months
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - PRO-CTCAE
The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) item library was developed to elicit symptomatic toxicity information directly from patients in cancer clinical trials. The items selected for this trial are: Mouth/throat sores, Taste changes, Decreased appetite, Nausea, Vomiting, Constipation, Diarrhoea, Shortness of breath, Cough, Rash, Skin dryness, Hair loss, Itching, Numbness \& Tingling, Fatigue, Nosebleed, Headache.
PRO-CTCAE responses are scored from 0 (=none) to 4 (=very severe) (or 0/1 for absent/present).
Measured: up to 24 weeks
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - EORTC IL46
The EORTC IL46 is a single question that assesses bother (burden) of treatment. It is rated on a scale from 1 to 4, ranging from "not at all" to "very much".
Measured: up to 48 weeks
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - EORTC IL19
The EORTC IL19 consists of five physical functioning scale items. It is rated on a scale from 1 to 4, ranging from "not at all" to "very much".
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start28 Jun 2024
- Primary completion8 Jan 2029 (estimated)
- Study completion8 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 768 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324357
- Sponsor's protocol ID
- 1479-0012
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Publications
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 Nov;21(26):3385-3393. doi: 10.1080/14796694.2025.2569553. Epub 2025 Oct 17.
PubMed 41108088
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)
- ClinicalTrials.gov ID
- NCT06324357
- Acronym / sponsor ID
- 1479-0012
- Conditions
- Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 768 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 8 Jan 2029 (estimated)
- Study completion
- 8 Jan 2029 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab and capecitabine, with zanidatamab, or with mFOLFOX6 (with or without trastuzumab). Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Phase Ib - Cohort A: zongertinib + Trastuzumab emtansine | Experimental | Drug: Zongertinib, Drug: Trastuzumab emtansineDose escalation (Phase Ib) |
| Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecan | Experimental | Drug: Zongertinib, Drug: Trastuzumab deruxtecanDose escalation (Phase Ib) |
| Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecan | Experimental | Drug: Zongertinib, Drug: Trastuzumab deruxtecanDose escalation (Phase Ib) |
| Phase II - Cohort D: zongertinib + Trastuzumab emtansine | Experimental | Drug: Zongertinib, Drug: Trastuzumab emtansineDose optimization (Phase II). |
| Phase II - Cohort E: zongertinib + Trastuzumab deruxtecan | Experimental | Drug: Zongertinib, Drug: Trastuzumab deruxtecanDose optimization (Phase II). |
| Phase II - Cohort F: zongertinib + Trastuzumab deruxtecan | Experimental | Drug: Zongertinib, Drug: Trastuzumab deruxtecanDose optimization (Phase II). |
| Phase Ib - Cohort G: zongertinib + trastuzumab + capecitabine | Experimental | Drug: Zongertinib, Drug: Trastuzumab, Drug: CapecitabineDose escalation (Phase Ib) |
| Phase Ib - Cohort K: zongertinib + trastuzumab | Experimental | Drug: Zongertinib, Drug: TrastuzumabDose escalation (Phase Ib) |
| Phase II - Cohort H: zongertinib + trastuzumab + capecitabine | Experimental | Drug: Zongertinib, Drug: Trastuzumab, Drug: CapecitabineDose optimization (Phase II). |
| Phase II - Cohort I: zongertinib | Experimental | Drug: ZongertinibDose optimization (Phase II). |
| Phase II - Cohort J: zongertinib + trastuzumab | Experimental | Drug: Zongertinib, Drug: TrastuzumabDose optimization (Phase II). |
| Phase II - Cohort I-ext: zongertinib | Experimental | Drug: ZongertinibExtension Phase II |
| Phase II - Cohort J-ext: zongertinib + trastuzumab | Experimental | Drug: Zongertinib, Drug: TrastuzumabExtension Phase II |
| Phase Ib - Cohort M: zongertinib + mFOLFOX6 | Experimental | Drug: Zongertinib, Drug: mFOLFOX6Dose escalation (Phase Ib) |
| Phase Ib - Cohort N: zongertinib + trastuzumab + mFOLFOX6 | Experimental | Drug: Zongertinib, Drug: Trastuzumab, Drug: mFOLFOX6Dose escalation (Phase Ib) |
| Phase Ib - Cohort O: zongertinib + zanidatamab | Experimental | Drug: Zongertinib, Drug: zanidatamabDose escalation (Phase Ib) - is not conducted in China or South Korea |
| Phase II - Cohort L: zongertinib + trastuzumab | Experimental | Drug: Zongertinib, Drug: TrastuzumabDose justification (Phase II) |
| Phase II - Cohort L-ext: zongertinib + trastuzumab | Experimental | Drug: Zongertinib, Drug: TrastuzumabExtension Phase II |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 informed consent form (ICF)
- Cohorts A to K and Cohort O: 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).
- Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2) overexpression/amplification according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) gastric cancer guidelines and according to the result of local testing.
- For dose optimization and justification (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible, collected through archival tissue
- History of prior treatment lines in palliative setting:
Key exclusion criteria (10 listed)
- Previous treatment with:
- Presence of uncontrolled and/or symptomatic brain metastases, or leptomeningeal disease
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZongertinibAlso: BI 1810631, Hernexeos®Zongertinib | Drug | Phase II - Cohort D: zongertinib + Trastuzumab emtansine, Phase II - Cohort E: zongertinib + Trastuzumab deruxtecan, Phase II - Cohort F: zongertinib + Trastuzumab deruxtecan, Phase II - Cohort H: zongertinib + trastuzumab + capecitabine, Phase II - Cohort I-ext: zongertinib, Phase II - Cohort I: zongertinib, Phase II - Cohort J-ext: zongertinib + trastuzumab, Phase II - Cohort J: zongertinib + trastuzumab, Phase II - Cohort L-ext: zongertinib + trastuzumab, Phase II - Cohort L: zongertinib + trastuzumab, Phase Ib - Cohort A: zongertinib + Trastuzumab emtansine, Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecan, Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecan, Phase Ib - Cohort G: zongertinib + trastuzumab + capecitabine, Phase Ib - Cohort K: zongertinib + trastuzumab, Phase Ib - Cohort M: zongertinib + mFOLFOX6, Phase Ib - Cohort N: zongertinib + trastuzumab + mFOLFOX6, Phase Ib - Cohort O: zongertinib + zanidatamab |
| Trastuzumab deruxtecanAlso: T-DXd; Enhertu®Trastuzumab deruxtecan | Drug | Phase II - Cohort E: zongertinib + Trastuzumab deruxtecan, Phase II - Cohort F: zongertinib + Trastuzumab deruxtecan, Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecan, Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecan |
| Trastuzumab emtansineAlso: T-DM1; Kadcyla®Trastuzumab emtansine | Drug | Phase II - Cohort D: zongertinib + Trastuzumab emtansine, Phase Ib - Cohort A: zongertinib + Trastuzumab emtansine |
| TrastuzumabHerceptin® | Drug | Phase II - Cohort H: zongertinib + trastuzumab + capecitabine, Phase II - Cohort J-ext: zongertinib + trastuzumab, Phase II - Cohort J: zongertinib + trastuzumab, Phase II - Cohort L-ext: zongertinib + trastuzumab, Phase II - Cohort L: zongertinib + trastuzumab, Phase Ib - Cohort G: zongertinib + trastuzumab + capecitabine, Phase Ib - Cohort K: zongertinib + trastuzumab, Phase Ib - Cohort N: zongertinib + trastuzumab + mFOLFOX6 |
| CapecitabineXeloda® | Drug | Phase II - Cohort H: zongertinib + trastuzumab + capecitabine, Phase Ib - Cohort G: zongertinib + trastuzumab + capecitabine |
| mFOLFOX6mFOLFOX6 | Drug | Phase Ib - Cohort M: zongertinib + mFOLFOX6, Phase Ib - Cohort N: zongertinib + trastuzumab + mFOLFOX6 |
| zanidatamabzanidatamab | Drug | Phase Ib - Cohort O: zongertinib + zanidatamab |
Primary outcome
Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Time frame: up to 21 days
The MTD evaluation period is defined as the first 21 days of the first treatment cycle for Cohorts A, B, C, G, K, and O. The MTD evaluation period is defined as the first 28 days after the first administration of any trial medication for Cohorts M and N.
Dose optimization and justification (Phase II): Objective response (OR)
Time frame: up to 50 months
Objective response (OR) is defined as the best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, or treatment discontinuation as assessed by investigator review.
13 secondary outcomes
Dose escalation (Phase Ib): Objective response (OR)
Time frame: up to 50 months
Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) during the entire treatment period
Time frame: up to 50 months
Dose escalation (Phase Ib): Maximum measured concentration of zongertinib (at steady state) (Cmax,(ss))
Time frame: up to 2 days
Dose escalation (Phase Ib): Area under the concentration-time curve of zongertinib over the time interval from 0 to 4h at steady state (AUC0-4h,ss)
Time frame: up to 2 days
Dose escalation (Phase Ib): Area under the concentration-time curve of zongertinib over the time interval from 0 to the last quantifiable data point at steady state (AUC0-tz,ss)
Time frame: up to 2 days
Dose optimization and justification (Phase II): Progression-free survival (PFS)
Time frame: up to 50 months
Dose optimization and justification (Phase II): Disease control (DC)
Time frame: up to 50 months
Dose optimization and justification (Phase II): Occurrence of treatment-emergent AEs leading to zongertinib (BI 1810631) dose reduction during the on-treatment period
Time frame: up to 50 months
Dose optimization and justification (Phase II): Maximum measured concentration (at steady state) (Cmax,(ss))
Time frame: up to 50 months
Dose optimization and justification (Phase II): Area under the concentration-time curve over the time interval from 0 to the last quantifiable data point at steady state (AUC0-tz,ss)
Time frame: up to 50 months
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - PRO-CTCAE
Time frame: up to 24 weeks
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - EORTC IL46
Time frame: up to 48 weeks
Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - EORTC IL19
Time frame: up to 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Derived from this study: PubMed 41108088Hurvitz 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 Nov;21(26):3385-3393. doi: 10.1080/14796694.2025.2569553. Epub 2025 Oct 17.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
104 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zongertinib, Trastuzumab deruxtecan and Trastuzumab emtansine in people with Metastatic Breast Cancer and Metastatic Gastric Adenocarcinoma, run by Boehringer Ingelheim at 104 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States, Spain, France, United Kingdom, China and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period (time frame: up to 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06324357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.