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Study identifier: NCT06324357 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Metastatic Breast Cancer · Metastatic Gastric Adenocarcinoma · Gastroesophageal Junction Adenocarcinoma  ·  Sponsor: Boehringer Ingelheim

PhasePhase 1/Phase 2
Planned participants768
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 p…

This description comes directly from the study's public registry record.

Talk to the study team

Boehringer Ingelheim  ·  1-800-243-0127  ·  clintriage.rdg@boehringer-ingelheim.com

Always discuss trial participation with your own doctor first.

Locations (105)

The Oncology Institute of Hope and InnovationCerritos, California, United StatesRecruiting
Ellison Medical InstituteLos Angeles, California, United StatesNot Yet Recruiting
Valkyrie Clinical TrialsLos Angeles, California, United StatesRecruiting
University of California Los AngelesLos Angeles, California, United StatesNot Yet Recruiting
University of California IrvineOrange, California, United StatesRecruiting
Sharp Memorial HospitalSan Diego, California, United StatesNot Yet Recruiting
Yale University School of MedicineNew Haven, Connecticut, United StatesRecruiting
Helios CR IncLakeland, Florida, United StatesRecruiting
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida, United StatesNot Yet Recruiting
Orchard Healthcare Research Inc.- SkokieSkokie, Illinois, United StatesNot Yet Recruiting
Community Health NetworkIndianapolis, Indiana, United StatesNot Yet Recruiting
University of Iowa Hospitals and ClinicsIowa City, Iowa, United StatesRecruiting

+ 93 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06324357