OncoMatch/Clinical Trials/NCT06324357
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
Is NCT06324357 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for metastatic breast cancer.
Treatment: Zongertinib · Trastuzumab deruxtecan · Trastuzumab emtansine · Trastuzumab · Capecitabine · mFOLFOX6 · zanidatamab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Gastric Cancer
Esophageal Carcinoma
Colorectal Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression
Documented Human epidermal growth factor receptor 2 overexpressing and/or amplified (HER2+)
Required: HER2 (ERBB2) amplification
Documented Human epidermal growth factor receptor 2 overexpressing and/or amplified (HER2+)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: HER2-targeted therapy — unresectable locally advanced or metastatic disease
documented investigator assessed progression after HER2-directed treatment for unresectable locally advanced or metastatic disease
Cannot have received: small molecule HER2 inhibitor
Exception: In Cohort D allowed in up to 15 patients in each dose level (DL)
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).
Cannot have received: antibody-drug conjugate (trastuzumab deruxtecan)
Exception: In Cohort E allowed in up to 15 patients in each DL
T-DXd in Cohorts E and F. In Cohort E allowed in up to 15 patients in each DL.
Cannot have received: antibody-drug conjugate (trastuzumab emtansine)
Exception: In Cohort H 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.
Cannot have received: antimetabolite (capecitabine)
Exception: In Cohort D 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
Lab requirements
Blood counts
Adequate organ function based on laboratory values
Kidney function
Adequate organ function based on laboratory values
Liver function
Adequate organ function based on laboratory values
Cardiac function
Ejection fraction <50% or the lower limit of normal of the institutional standard within 28 days prior to randomization [excluded]
Adequate organ function based on laboratory values; Ejection fraction <50% or the lower limit of normal of the institutional standard within 28 days prior to randomization [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic-Arizona · Phoenix, Arizona
- The Oncology Institute of Hope and Innovation · Cerritos, California
- Ellison Medical Institute · Los Angeles, California
- Valkyrie Clinical Trials · Los Angeles, California
- University of California Los Angeles · Los Angeles, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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