Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations

September 14, 2026 updated by: Boehringer Ingelheim

Beamion PANTUMOR-1: A Phase II, Multicentre, Multicohort, Open-label Trial to Evaluate the Efficacy and Safety of Oral Zongertinib (BI 1810631) for the Treatment of Selected HER2-mutated or Overexpressed/Amplified Solid Tumours

This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study. The purpose of this study is to find out whether a medicine called zongertinib helps people with advanced cancers with HER2 alterations. HER2 alterations can cause cancer. Zongertinib inhibits HER2.

Participants are put into groups based on the type of advanced cancer they have, the type of HER2 alterations they have, and the dose of zongertinib they receive. Depending on the group they are in, participants take 1 of 2 different doses of zongertinib each day. Participants can continue the treatment as long as they benefit from it and can tolerate it.

Participants visit the study site regularly. During many of the visits, the doctors check the size of the tumour and whether it has spread to other parts of the body. During all the visits, the doctors check participants' health and take note of any unwanted effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

588

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2109
      • St Leonards, New South Wales, Australia, 2065
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc
        • Contact:
      • Edegem, Belgium, 2650
        • Recruiting
        • Universitair Ziekenhuis Antwerpen
        • Contact:
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute (University of Alberta)
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BC Cancer Agency - Vancouver
        • Contact:
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre hospitalier de l'Université de Montréal (CHUM)
        • Contact:
      • Montreal, Quebec, Canada, H4A 3J1
        • Completed
        • McGill University Health Centre (MUHC)
  • China
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
      • Changsha, China, 410013
        • Not yet recruiting
        • Hunan Province Tumor Hospital
        • Contact:
      • Hangzhou, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
        • Contact:
      • Hefei, China, 230001
        • Recruiting
        • AnHui Provincial Cancer Hospital
        • Contact:
      • Nanchang, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanjing, China, 210008
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Shanghai, China, 200120
        • Recruiting
        • Shanghai East Hospital
        • Contact:
      • Shanghai, China, 200131
        • Recruiting
        • Shanghai GoBroad Cancer Hospital
        • Contact:
      • Wuhan, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University Of Science And Technology
        • Contact:
      • Wuhan, China, 430030
        • Not yet recruiting
        • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
        • Contact:
      • Zhengzhou, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
  • France
      • Bordeaux, France, 33000
      • Dijon, France, 21079
        • Recruiting
        • CTR Georges-François Leclerc
        • Contact:
      • Lyon, France, 69373
      • Marseille, France, 13385
      • Poitiers, France, 86000
      • Villejuif, France, 94805
  • Germany
      • Berlin, Germany, 12203
      • Giessen, Germany, 35392
      • Hamburg, Germany, 22763
      • Leipzig, Germany, 04103
      • Mannheim, Germany, 68167
      • München, Germany, 81675
        • Recruiting
        • Klinikum rechts der Isar der Technischen Universität München
        • Contact:
  • Italy
      • Ancona, Italy, 60020
        • Recruiting
        • Az. Ospedaliere Umberto I di Ancona
        • Contact:
      • Aviano (PN), Italy, 33081
        • Not yet recruiting
        • Centro di Riferimento Oncologico
        • Contact:
      • Meldola (FC), Italy, 47014
        • Recruiting
        • Istituto Scientifico Romagnolo
        • Contact:
      • Milan, Italy, 20162
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda
        • Contact:
      • Naples, Italy, 80131
        • Recruiting
        • AOU Università degli Studi della Campania Luigi Vanvitelli
        • Contact:
      • Rome, Italy, 00128
        • Not yet recruiting
        • Fondazione Policlinico Universitario Campus Bio-Medico
        • Contact:
  • Japan
      • Aichi, Nagoya, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital
        • Contact:
      • Chiba, Kashiwa, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
      • Okayama, Okayama, Japan, 700-8558
        • Not yet recruiting
        • Okayama University Hospital
        • Contact:
      • Osaka, Osaka, Japan, 541-8567
        • Recruiting
        • Osaka International Cancer Institute
        • Contact:
      • Shizuoka, Sunto-gun, Japan, 411-8777
      • Tokyo, Chuo-ku, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
        • Contact:
      • Tokyo, Koto-ku, Japan, 135-8550
        • Recruiting
        • Japanese Foundation for Cancer Research
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
      • Nijmegen, Netherlands, 6525 GL
        • Recruiting
        • Radboud Universitair Medisch Centrum
        • Contact:
  • Norway
      • Oslo, Norway, N-0379
        • Recruiting
        • Oslo Universitetssykehus HF, Radiumhospitalet
        • Contact:
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
  • Singapore
      • Singapore, Singapore, 168583
  • South Korea
      • Seoul, South Korea, 05505
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea, 03722
      • Seoul, South Korea, 135-710
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruña
        • Contact:
      • Badalona, Spain, 08916
        • Not yet recruiting
        • Hospital Germans Trías i Pujol
        • Contact:
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08908
        • Not yet recruiting
        • Hospital Duran i Reynals
        • Contact:
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
      • Madrid, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra - Madrid
        • Contact:
      • Pamplona, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Virgen Del Rocio
        • Contact:
      • Valencia, Spain, 46010
        • Not yet recruiting
        • Hospital Clinico De Valencia (INCLIVA)
        • Contact:
  • United Kingdom
      • Dundee, United Kingdom, DD1 9SY
      • London, United Kingdom, W12 0HS
      • Manchester, United Kingdom, M20 4BX
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Completed
        • University of Arizona Comprehensive Cancer Center
    • California
      • Beverly Hills, California, United States, 90212
      • La Jolla, California, United States, 92037
      • Los Angeles, California, United States, 90067
    • Connecticut
      • New Haven, Connecticut, United States, 06511
    • Florida
      • Tamarac, Florida, United States, 33321
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
    • Indiana
      • Indianapolis, Indiana, United States, 46219
        • Recruiting
        • Community MD Anderson Cancer Center - East Medical Oncology
        • Contact:
    • Maryland
      • Columbia, Maryland, United States, 21044
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Completed
        • Karmanos Cancer Institute
    • New Mexico
      • Albuquerque, New Mexico, United States, 87110
    • New York
      • New York, New York, United States, 10029
      • New York, New York, United States, 10065
    • Ohio
      • Maumee, Ohio, United States, 43537
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Sarah Cannon Research Institute at Mary Crowley
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
      • Plano, Texas, United States, 75093
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Patients aged ≥18 years
  • Documented Human epidermal growth factor receptor 2 (HER2)-positive status or known activating HER2 mutations (by local testing)
  • Histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumours
  • Disease progression following prior treatment in the metastatic setting (including treatment with antibody-drug conjugates (ADCs)) and no suitable standard of care treatment options
  • Availability of archival tumour tissue sample to confirm HER2 status
  • Presence of ≥1 measurable lesion outside the central nervous system (CNS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (investigator assessed)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Further inclusion criteria apply.

Exclusion criteria:

  • Diagnosis of HER2-positive (overexpressed/amplified) metastatic breast cancer or metastatic gastroesophageal adenocarcinoma
  • Diagnosis of HER2-mutant non-small cell lung cancer (NSCLC)
  • Previous treatment with any HER2 tyrosine kinase inhibitors (TKIs)
  • Previous or concomitant malignancies other than the one treated in this trial within the previous 3 years except the following effectively treated cancers: nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, localized prostate cancer on watchful waiting or active surveillance, and other effectively treated malignancies that are considered cured by local treatment
  • Uncontrolled or symptomatic brain or subdural metastases during screening
  • Known diagnosis of leptomeningeal disease
  • Intake of restricted medications or any drug considered likely to interfere with the trial being conducted in a safe mannerFurther exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zongertinib treatment
Drug: Zongertinib
Zongertinib
Other Names:
  • BI 1810631, Hernexeos®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with objective response (OR)
Time Frame: Up to 51 months
according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 by central independent review, and it will be summarised descriptively as absolute and relative frequencies
Up to 51 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of objective response (DOR)
Time Frame: Up to 51 months
Duration of objective response (DOR) is defined as the time from first documented Objective response (OR) according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed OR, assessed by central independent review.
Up to 51 months
Progression-Free Survival (PFS)
Time Frame: Up to 51 months
PFS is defined as the time from treatment start until the earliest date of tumour progression according to RECIST 1.1 assessed by central independent review, or death from any cause, whichever occurs first.
Up to 51 months
Disease control (DC)
Time Frame: Up to 51 months
Disease control (DC) is defined as best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) where BOR is defined according to RECIST 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, or treatment discontinuation, as assessed by central independent review.
Up to 51 months
Occurrence of treatment-emergent Adverse Events (AEs)
Time Frame: Up to 51 months
Up to 51 months
Overall survival (OS)
Time Frame: Up to 51 months
OR is defined as the time from start of treatment to death from any cause
Up to 51 months
Change from baseline to Week 48 or progressive disease (PD) by central independent review, if earlier, of the EORTC QLQ-C30, which includes IL-19, the physical functioning scale
Time Frame: At baseline and up to 48 weeks
QLQ-C30 incorporates both multi-items scales and single-item measures. These include 1 global health status/QoL scale, 5 functional scales, 3 symptoms scales and 6 single items to assess dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. European Organisation for Research and Treatment of Cancer, quality-of-life questionnaire (EORTC QLQ-C30) does not produce a single overall summary score by default. Scores can be reported via domain-specific scores or summary score (since 2016) ranging from 0 to 100 with higher scores representing a better QoL.
At baseline and up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2024

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

December 29, 2028

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 1479-0009
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2023-510429-14-00 (Registry Identifier: CTIS)
  • U1111-1302-3333 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section 'time frame' are fulfilled, researchers can use the following link hhttps://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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