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Finding the right dose of zongertinib for HER2+ cancer treatment

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)

PHASE1; PHASE2 · Boehringer Ingelheim · NCT06324357

This study is testing the best dose of zongertinib to see if it can help adults with hard-to-treat HER2+ cancers shrink their tumors.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment768 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim (industry)
Drugs / interventionstrastuzumab, zanidatamab, zongertinib
Locations108 sites (Phoenix, Arizona and 107 other locations)
Trial IDNCT06324357 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine the optimal dose of zongertinib, a drug that inhibits HER2, for adults with various types of HER2+ cancers that have metastasized and are inoperable. Participants will receive zongertinib either alone or in combination with other treatments such as trastuzumab deruxtecan, trastuzumab emtansine, or capecitabine. The study is divided into two parts: the first part focuses on dose escalation, while the second part evaluates the effectiveness of the selected doses in shrinking tumors. Eligible patients must have documented HER2+ cancer and have not responded to previous treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with HER2+ metastatic breast cancer or other specified HER2+ cancers that cannot be surgically removed.

Not a fit: Patients with HER2-negative cancers or those who have not recovered from previous therapy-related toxicities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced HER2+ cancers.

How similar studies have performed: Other studies targeting HER2+ cancers have shown promising results, indicating that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

* 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
* Adequate organ function based on laboratory values Further inclusion criteria apply.

Exclusion criteria:

* 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
* 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.

Where this trial is running

Phoenix, Arizona and 107 other locations

+58 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, Colorectal Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.