Tests zongertinib alone or with other drugs in HER2-positive cancers that have spread
Tests zongertinib, alone or combined, in adults with HER2-positive cancers that have spread.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Bordeaux, Caen, Lyon, Marseille, Paris, Rennes, Saint-Herblain, Strasbourg, Toulouse, and Villejuif, FranceSee the 10 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with HER2-positive breast, stomach, food pipe or bowel cancer that has spread, to test zongertinib alone or with other drugs.
- Age
- 18 years or older (or above the legal age of consent where that is higher than 18).
- Sex
- All sexes can join.
- Disease stage
- Metastatic (spread) HER2-positive breast cancer, or adenocarcinoma of the stomach, gastroesophageal junction or esophagus, or colorectal cancer. At least one measurable tumour (RECIST 1.1). ECOG score 0 or 1.
- Earlier treatment
- For most cohorts, the cancer must have grown during earlier treatment given for advanced disease, as judged by the investigator.
- Biomarker or test result
- Documented HER2 overexpression and/or amplification (HER2+). Tumour tissue must be provided in Phase II.
Main reasons for not taking part
- QTcF longer than 470 msec, or other risks for heart rhythm problems such as heart failure, low potassium or long QT syndrome
- Ejection fraction below 50% or below the lower limit of normal at the site
- History of interstitial lung disease or pneumonitis that needed steroids, current disease, or suspected disease that imaging cannot rule out
Read by machine on 12 November 2026.
Where in France
- INS BergonieBordeaux, FranceContact: Boehringer IngelheimTaking people
- CTR François BaclesseCaen, FranceContact: Boehringer IngelheimTaking people
- CTR Leon BerardLyon, FranceContact: Boehringer IngelheimTaking people
- INS Paoli-CalmettesMarseille, FranceContact: Boehringer IngelheimTaking people
- HOP TenonParis, FranceContact: Boehringer IngelheimTaking people
- CTR Eugène MarquisRennes, FranceContact: Boehringer IngelheimNot yet recruiting
- Institut de Cancérologie de l'OuestSaint-Herblain, FranceContact: Boehringer IngelheimTaking people
- Institut de Cancérologie de StrasbourgStrasbourg, FranceContact: Boehringer IngelheimTaking people
- INS Claudius Regaud IUCT-OncopoleToulouse, FranceContact: Boehringer IngelheimTaking people
- Institut Gustave RoussyVillejuif, FranceContact: Boehringer IngelheimTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Boehringer Ingelheim
- Trial code
- NCT06324357
- Record updated
- 5 November 2026
- Original description
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 alone or together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab with or without capecitabine, with zanidatamab with or without docetaxel, 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.Read full original descriptionShow less
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 alone or together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab with or without capecitabine, with zanidatamab with or without docetaxel, 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 alone or 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.
Inclusion: 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 and P: 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; For (Phase II): Patient must provide tumor 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, O and P documented investigator assessed progression; 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.
Exclusion: 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; 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.