Evidence map›Paper›PMID 41108088›Full record

ArticleFuture oncology (London, England)2025

Beamion BCGC-1: phase Ib/II trial of zongertinib for advanced HER2-positive breast or gastroesophageal cancers.

Sara Hurvitz, Matteo Simonelli, Ramón Yarza, David Berz, Shigehisa Kitano, Gianluca Del Conte, Daniel Acosta Eyzaguirre, Bernard Gaston Doger de Speville Uribe, Daniela Maier, Damijan Erzen and 8 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Future oncology (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06324357 (Beamion BCGC-1), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06324357 phase1 / phase2recruitingnot on this map

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)

TypeinterventionalSponsorBoehringer IngelheimRan2024 to 2029Enrolled768ConditionsMetastatic Breast Cancer, Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal AdenocarcinomaArmsZongertinib, Trastuzumab deruxtecan, Trastuzumab emtansine, Trastuzumab, Capecitabine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Antibody-Drug Conjugates in the Treatment of Esophageal Cancer.Current treatment options in oncology · 2026
    Review
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Sara HurvitzClinical Research Division, Fred Hutchinson Cancer Center, Division of Hematology/Oncology, Department of Medicine, The University of Washington, Seattle, WA, USA.
Matteo SimonelliDepartment of Medical Oncology and Hematology, IRCCS Humanitas Research Hospital, Milan, Italy.
Ramón YarzaDrug Development and Phase 1 Unit, START CIOCC, Madrid, Spain.
David BerzDepartment of Oncology, Valkyrie Clinical Trials, Inc, Los Angeles, CA, USA.
Shigehisa KitanoDepartment of Advanced Medical Development, Japanese Foundation for Cancer Research, Tokyo, Japan.
Gianluca Del ConteDepartment of Oncology, IRCCS San Raffaele Scientific Institute Hospital, Milan, Italy.
Daniel Acosta EyzaguirreMedical Oncology Department, Vall d'Hebron University Hospital, VHIO, Barcelona, Spain.
Bernard Gaston Doger de Speville UribeMedical Oncology, START Madrid, Fundación Jiménez Díaz, Spain.
Daniela MaierBiostatistics and Data Sciences, Boehringer Ingelheim Pharma Gmbh & Co., KG, Biberach an der Riss, Germany.
Damijan ErzenBiostatistics and Data Sciences, Boehringer Ingelheim Pharma Gmbh & Co., KG, Biberach an der Riss, Germany.
Sila Aykut YazgiliGlobal Clinical Development & Operations, Boehringer Ingelheim Pharma Gmbh & Co., KG, Ingelheim am Rhein, Germany.
Giuseppe CuriglianoDivision of Early Drug Development, European Institute of Oncology, IRCCS, Milan, Italy.
Ting DengNational Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Min YanDepartment of Breast Disease, Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.
Qingyuan ZhangDepartment of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
Xian WangDepartment of Oncology, Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou, China.
Izuma NakayamaDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
Kohei ShitaraDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOverexpression and/or amplification of human epidermal growth factor receptor 2 (HER2) is a recognized oncogenic driver in metastatic breast cancer (mBC) and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinomas (mGEAC). Although HER2-directed monoclonal antibodies, antibody - drug conjugates (ADCs), and tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of HER2-positive tumors, additional combination regimens and/or novel agents are needed to expand sequential therapy options and improve patient outcomes - particularly following treatment with trastuzumab deruxtecan (T-DXd). Zongertinib is a novel, irreversible, HER2-selective TKI that spares EGFR. STUDY

designHere, we detail the rationale and design of Beamion BCGC-1 (NCT06324357), an international Phase Ib/II open-label trial in which patients with previously treated HER2-positive mBC or mGEAC will receive zongertinib alone or in combination. Phase Ib (dose escalation) will determine the maximum tolerated dose of zongertinib plus trastuzumab emtansine (T-DM1), T-DXd, or trastuzumab ± capecitabine, in patients with HER2-positive mBC, and plus T-DXd in patients with HER2-positive mGEAC. Phase II (dose optimization) will assess two doses of zongertinib in combination regimens, or as monotherapy, in patients with mBC or mGEAC. The trial is actively recruiting in six countries globally. CLINICAL

trial registrationwww.clinicaltrials.gov identifier is NCT06324357.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesEsophageal NeoplasmsIsoxazolesStomach NeoplasmsAdenocarcinomaAdo-Trastuzumab EmtansineAnilidesCamptothecinClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicEsophagogastric JunctionFemaleHumansImmunoconjugatesAdo-Trastuzumab EmtansineAnilidesCamptothecinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesGSK 1363089ImmunoconjugatesIsoxazolesProtein Kinase InhibitorsQuinolinesTrastuzumabtrastuzumab deruxtecanHER2metastatic breast cancermetastatic gastric, gastroesophageal junction, or esophageal adenocarcinomaphase Ib/II clinical trialtrastuzumabtrastuzumab deruxtecantrastuzumab emtansineZongertinib

Identifiers

PMID41108088
PMCPMC12582115

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.