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Taking people in United KingdomPhase 1/2

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.

Key facts

Who runs it
Boehringer Ingelheim
Where
Cardiff, Leeds, London, Manchester, Newcastle upon Tyne, Nottingham, and Sutton, United KingdomSee the 10 sitesAlso in 9 other countries, 93 sites
Trial code
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
Status
Recruiting
Phase
Phase 1/2
People taking part
910 people, planned
Started
28 Jun 2024
Expected to end
8 Jan 2029
Type of study
Interventional, 19 groups
Treatments tested
  • Zongertinib
  • Trastuzumab deruxtecan
  • Trastuzumab emtansine
  • Trastuzumab
  • Capecitabine
  • mFOLFOX6
  • zanidatamab
  • Docetaxel
Record updated
5 November 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in United Kingdom

Also in 9 other countries, 93 sites

  • Velindre Cancer CentreCardiff, United KingdomContact: Boehringer IngelheimTaking people
  • St James's University HospitalLeeds, United KingdomContact: Boehringer IngelheimTaking people
  • Royal Free HospitalLondon, United KingdomContact: Boehringer IngelheimTaking people
  • St. Bartholomew's HospitalLondon, United KingdomContact: Boehringer IngelheimNot yet recruiting
  • The Royal Marsden Hospital, ChelseaLondon, United KingdomContact: Boehringer IngelheimTaking people
  • University College HospitalLondon, United KingdomContact: Boehringer IngelheimTaking people
  • The ChristieManchester, United KingdomContact: Boehringer IngelheimTaking people
  • Freeman HospitalNewcastle upon Tyne, United KingdomContact: Boehringer IngelheimTaking people
  • Nottingham University HospitalNottingham, United KingdomContact: Boehringer IngelheimNot yet recruiting
  • The Royal Marsden Hospital, SuttonSutton, United KingdomContact: Boehringer IngelheimTaking people

About the trial

What the trial wants to find out

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

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.

The 19 groups in the trial

  • Phase Ib - Cohort A: zongertinib + Trastuzumab emtansineTreatment being tested

    Dose escalation (Phase Ib)

    Treatment: Zongertinib and Trastuzumab emtansine

  • Phase Ib - Cohort B: zongertinib + Trastuzumab deruxtecanTreatment being tested

    Dose escalation (Phase Ib)

    Treatment: Zongertinib and Trastuzumab deruxtecan

  • Phase Ib - Cohort C: zongertinib + Trastuzumab deruxtecanTreatment being tested

    Dose escalation (Phase Ib)

    Treatment: Zongertinib and Trastuzumab deruxtecan

  • Phase II - Cohort D: zongertinib + Trastuzumab emtansineTreatment being tested

    Dose optimization (Phase II).

    Treatment: Zongertinib and Trastuzumab emtansine

  • Phase II - Cohort E: zongertinib + Trastuzumab deruxtecanTreatment being tested

    Dose optimization (Phase II).

    Treatment: Zongertinib and Trastuzumab deruxtecan

  • Phase II - Cohort F: zongertinib + Trastuzumab deruxtecanTreatment being tested

    Dose optimization (Phase II).

    Treatment: Zongertinib and Trastuzumab deruxtecan

  • Phase Ib - Cohort G: zongertinib + trastuzumab + capecitabineTreatment being tested

    Dose escalation (Phase Ib)

    Treatment: Zongertinib, Trastuzumab, and Capecitabine

  • Phase Ib - Cohort K: zongertinib + trastuzumabTreatment being tested

    Dose escalation (Phase Ib)

    Treatment: Zongertinib and Trastuzumab

  • Phase II - Cohort H: zongertinib + trastuzumab + capecitabineTreatment being tested

    Dose optimization (Phase II).

    Treatment: Zongertinib, Trastuzumab, and Capecitabine

  • Phase II - Cohort I: zongertinibTreatment being tested

    Dose optimization (Phase II).

    Treatment: Zongertinib

  • Phase II - Cohort J: zongertinib + trastuzumabTreatment being tested

    Dose optimization (Phase II).

    Treatment: Zongertinib and Trastuzumab

  • Phase II - Cohort I-ext: zongertinibTreatment being tested

    Extension Phase II

    Treatment: Zongertinib

  • Phase II - Cohort J-ext: zongertinib + trastuzumabTreatment being tested

    Extension Phase II

    Treatment: Zongertinib and Trastuzumab

  • Phase Ib - Cohort M: zongertinib + mFOLFOX6Treatment being tested

    Dose escalation (Phase Ib)

    Treatment: Zongertinib and mFOLFOX6

  • Phase Ib - Cohort N: zongertinib + trastuzumab + mFOLFOX6Treatment being tested

    Dose escalation (Phase Ib)

    Treatment: Zongertinib, Trastuzumab, and mFOLFOX6

  • Phase Ib - Cohort O: zongertinib + zanidatamabTreatment being tested

    Dose escalation (Phase Ib) - is not conducted in China or South Korea

    Treatment: Zongertinib and zanidatamab

  • Phase Ib - Cohort P: zongertinib + zanidatamab + docetaxelTreatment being tested

    Dose escalation (Phase 1b) - is not conducted in China or South Korea

    Treatment: Zongertinib, zanidatamab, and Docetaxel

  • Phase II - Cohort L: zongertinib + trastuzumabTreatment being tested

    Dose justification (Phase II)

    Treatment: Zongertinib and Trastuzumab

  • Phase II - Cohort L-ext: zongertinib + trastuzumabTreatment being tested

    Extension Phase II

    Treatment: Zongertinib and Trastuzumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Tests zongertinib alone or with other drugs in HER2-positive cancers that have spreadGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
5 November 2026