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

Brief summary (registry, in English)

Dose escalation (Phase Ib) • 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

What you commit to

• Study type: Interventional · Phase 1/2
• Planned participants: 181
• 45 sites in 5 countries
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

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

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (45)

Sites in registry order. Save your city in your profile to sort them by distance.

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