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Beamion BCGC-1: Zongertinib for HER2+ Cancers

This study is for adults aged 18 and older with certain types of HER2-positive (HER2+) cancer that has spread and cannot be removed by surgery. You may be able to join if your tumors show HER2 changes and previous treatments haven't worked. The study is testing zongertinib, a drug that blocks HER2 (a protein that can make cancer cells grow), both alone and in combination with other treatments like trastuzumab deruxtecan, trastuzumab emtansine, trastuzumab with capecitabine, or other regimens. The main goals are to find the safest and most effective dose of zongertinib and to see if it can shrink tumors. The study plans to enroll 768 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 768 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure objective response for up to 50 months.

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NCT06324357

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Boehringer Ingelheim
~768 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:ZongertinibTrastuzumab deruxtecanTrastuzumab emtansineTrastuzumabCapecitabinemFOLFOX6

At a glance

Recruiting sites
90 of 105 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Measured over up to 21 days
+1 more outcome measured

Conditions

Metastatic Breast Cancer
Metastatic Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Esophageal Adenocarcinoma
Colorectal Cancer

Explore related trials

Breast CarcinomaColorectal CarcinomaEsophageal AdenocarcinomaGastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

Where it's being run

105 sites across 24 states
Spain14
France11
United Kingdom10
China8
Italy8
Japan8
South Korea8
California6

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
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Eligibility criteria

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: 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 according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) gastric cancer guidelines and according to the result of local testing.
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 after HER2-directed treatment for unresectable locally advanced or metastatic disease (For Cohorts D, H, I (I-ext), J (J-ext) - patients must have been pretreated with trastuzumab deruxtecan (T-DXd) and have progressed or have been intolerant to previous T-DXd).
For cohorts L, L-ext, M and N documented progression or recurrence of disease during or following their latest line of therapy. Patients must have had at least one prior line of therapy for locally advanced unresectable disease or metastatic disease (adjuvant and neoadjuvant therapy excluded) and documented disease progression or recurrence of disease during or following their latest line of therapy. In the opinion of the Investigator, patients must be unlikely to tolerate or derive clinically meaningful benefit from further standard of care therapy known to prolong survival.
Presence of at least one measurable lesion according to RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

Exclusion

Previous treatment with:
Any small molecule HER2 inhibitor in the palliative setting in Cohorts D, E, F, H, L, L-ext, M, and N. In Cohort D allowed in up to 15 patients in each dose level (DL).
T-DXd in Cohorts E and F. In Cohort E allowed in up to 15 patients in each DL.
trastuzumab emtansine (T-DM1) in the palliative setting in Cohort D and H. In Cohort H allowed in up to 15 patients in each DL.
Capecitabine in Cohort D and H. In Cohort D allowed in up to 15 patients in each DL
Presence of uncontrolled and/or symptomatic brain metastases, or leptomeningeal disease
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

What this trial measures

  • Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation periodup to 21 days

    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.

  • Dose optimization and justification (Phase II): Objective response (OR)up to 50 months

    Objective response (OR) is defined as the best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, or treatment discontinuation as assessed by investigator review.