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
Public ClinicalTrials.gov record NCT06324357. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06324357
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 768 participants
Conditions and interventions
Conditions
Interventions
- Zongertinib Drug
- Trastuzumab deruxtecan Drug
- Trastuzumab emtansine Drug
- Trastuzumab Drug
- Capecitabine Drug
- mFOLFOX6 Drug
- zanidatamab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 27, 2024
- Primary completion
- Jan 7, 2029
- Completion
- Jan 7, 2029
- Last update posted
- Aug 5, 2026
2024 – 2029
United States locations
- U.S. sites
- 26
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Oncology Institute of Hope and Innovation | Cerritos | California | 90703 | Recruiting |
| Ellison Medical Institute | Los Angeles | California | 90064 | Not yet recruiting |
| Valkyrie Clinical Trials | Los Angeles | California | 90067 | Recruiting |
| University of California Los Angeles | Los Angeles | California | 90095 | Recruiting |
| University of California Irvine | Orange | California | 92868 | Recruiting |
| Sharp Memorial Hospital | San Diego | California | 92123 | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | Recruiting |
| Helios CR Inc | Lakeland | Florida | 33812 | Recruiting |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | Recruiting |
| Orchard Healthcare Research Inc.- Skokie | Skokie | Illinois | 60077 | Not yet recruiting |
| Community Health Network | Indianapolis | Indiana | 46250 | Recruiting |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| University of Michigan | Ann Arbor | Michigan | 48109 | Not yet recruiting |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| New York Cancer & Blood Specialists | Shirley | New York | 11967 | Not yet recruiting |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | Not yet recruiting |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | Recruiting |
| Baptist Cancer Center - Memphis | Memphis | Tennessee | 38120 | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | Recruiting |
| Tennessee Oncology, Pllc | Nashville | Tennessee | 37203 | Recruiting |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Not yet recruiting |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | Recruiting |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | Recruiting |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 79 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06324357, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 5, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06324357 live on ClinicalTrials.gov.