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Taking people in BelgiumPhase 1/2

Tests zongertinib alone and with other drugs in HER2-positive cancers that have spread

Tests zongertinib with other drugs in adults with HER2-positive advanced breast, stomach, or colorectal cancer.

Key facts

Who runs it
Boehringer Ingelheim International GmbH
Where
Edegem, Leuven, Libramont-Chevigny, Namur, and Sint-Lambrechts-Woluwe, BelgiumSee the 5 sitesAlso in 4 other countries, 40 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
181 people, planned
Started
5 Aug 2024
Expected to end
1 Aug 2029
Type of study
Interventional
Record updated
25 May 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, esophageal or colorectal cancer that has spread and that has grown after earlier treatment.

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, stomach, gastroesophageal junction or esophageal adenocarcinoma, or colorectal cancer with HER2 overexpression/amplification. At least one lesion that can be measured by RECIST 1.1. ECOG score of 0 or 1.
Earlier treatment
The cancer must have grown (progressed) during or after earlier treatment lines in the palliative setting. For the colorectal cohorts, progression or recurrence during or after the latest line of therapy.
Biomarker or test result
Documented HER2-positive cancer, or HER2 overexpression/amplification for colorectal cancer. For the Phase II part, tumor tissue is needed, ideally archival tissue from a site not radiated before biopsy.

Main reasons for not taking part

  • Mean resting corrected QT interval (QTcF) above 470 msec
  • Factors that raise the risk of QTc prolongation or irregular heart rhythm, such as heart failure, low potassium or long QT syndrome
  • Ejection fraction (heart pumping measure) below 50% or below the lower limit of normal within 28 days before randomization
  • History of interstitial lung disease/pneumonitis that needed steroids, or current or suspected ILD/pneumonitis

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: Documented HER2+ mBC or mGEAC
  • Cohorts L (L-ext), M, and N (mCRC): Documented HER2 overexpression/amplification
  • For dose optimization and justification (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible, collected through archival 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 and O documented investigator assessed progression; - For cohorts L, L-ext, M and N documented progression or recurrence of disease during or following their latest line of therapy
  • 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

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
  • Mean resting corrected QT interval (QTcF) >470 msec
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, 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 Belgium

Also in 4 other countries, 40 sites

  • Antwerp University HospitalEdegem, BelgiumTaking people
  • UZ LeuvenLeuven, BelgiumTaking people
  • Hopital De LibramontLibramont-Chevigny, BelgiumTaking people
  • Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-NamurNamur, BelgiumTaking people
  • Cliniques Universitaires Saint-LucSint-Lambrechts-Woluwe, BelgiumTaking people

About the trial

What the trial wants to find out

Dose escalation (Phase Ib)

Read full original descriptionShow less

• To characterize the safety, tolerability, and the dose-toxicity curve of zongertinib: o in combination with T-DM1 in patients with HER2+ mBC (Cohort A) o in combination with T-DXd in patients with HER2+ mBC (Cohort B) o in combination with T-DXd in patients with mGEAC (Cohort C) o in combination with capecitabine and trastuzumab in patients with HER2+ mBC (Cohort G) o in combination with trastuzumab in patients with HER2+ mBC (Cohort K) o in combination with mFOLFOX6 in patients with HER2+ mCRC (Cohort M) o in combination with trastuzumab and mFOLFOX6 in patients with HER2+ mCRC (Cohort N) o in combination with zanidatamab in patients with HER2+ mBC (Cohort O) by assessing escalating dose levels with overdose control to achieve primary objective of determining maximum tolerated doses (MTDs) and/or doses for further development per cohort

• To evaluate number of patients with "redacted as CCI" within MTD evaluation period per dose level. The MTD evaluation period is defined as the first 21 days of the first treatment cycle for Cohorts A, B, C, G, K, and O. The MTD evaluation period is defined as the first 28 days after the first administration of any trial medication for Cohorts M and N. The MTD is to be determined by dose escalation committee (DEC) based on the totality of data. It may be chosen as the highest dose with less than 25% risk of the true DLT rate being equal to or above 33% during MTD evaluation period based on the Bayesian Logistic Regression Model (BLRM) with overdose control (escalation with overdose control [EWOC]) for the trial

• The primary characterization of primary objective will be based on initial dose administered to patient during the MTD evaluation period and the strategy for handling intercurrent events will be a combined composite and principal stratum approach where some intercurrent events are considered as outcome and some define population consisting of patients who are able to adhere to the assigned treatment regimen and trial schedule

Dose optimization and justification (Phase II)

• To assess anti-tumor activity of zongertinib in the following settings to assist in selection of optimal dose for further clinical development: o in combination with T-DM1 in patients with HER2+ mBC (Cohort D) o in combination with T-DXd in patients with HER2+ mBC (Cohort E) o in combination with T-DXd in patients with HER2+ mGEAC (Cohort F) o in combination with capecitabine and trastuzumab in patients with HER2+ mBC (Cohort H) o as a monotherapy in patients with HER2+ mBC (Cohort I, I-ext) o in combination with trastuzumab in patients with HER2+ mBC (Cohort J, J-ext) o in combination with trastuzumab in patients with HER2+ mCRC (Cohort L, L-ext)

• The primary endpoint is proportion of patients with objective response (OR) by RECIST version 1.1 as assessed by investigator review in the intent-to-treat population

• The summary measure of OR will include all treated patients regardless of breaks from trial treatment but will exclude the effects of any subsequent anti-cancer therapy started before progression

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

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
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 and 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 9 November 2026.
Record updated
25 May 2026