Solid TumoursPhase 2NCT06581432
Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
A Phase 2 study testing Zongertinib in people with Solid Tumours, run by Boehringer Ingelheim at 92 sites in 16 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours
- What is being tested?
- Zongertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 588 participants
- Where
- 92 sitesin 16 countries
- Study dates
- 11 Oct 2024to 29 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of HER2-positive (overexpressed/amplified) metastatic breast cancer
- 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.
Trial locations and contacts
92 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
92 sites in 16 countries
United States20 sites, 18 recruiting
- Recruiting
Presbyterian Healthcare Services
Albuquerque, New Mexico, 87110
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Alaska Oncology and Hematology, LLC
Anchorage, Alaska, 99508
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Precision NextGen Oncology
Beverly Hills, California, 90212
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Maryland Oncology Hematology, Columbia
Columbia, Maryland, 21044
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, 75230
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Completed
Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Community MD Anderson Cancer Center - East Medical Oncology
Indianapolis, Indiana, 46219
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Scripps Cancer Center Torrey Pines
La Jolla, California, 92037
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Taylor Cancer Research Center
Maumee, Ohio, 43537
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06511
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Texas Oncology - Plano West
Plano, Texas, 75093
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
BRCR Global - Tamarac
Tamarac, Florida, 33321
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Completed
University of Arizona Comprehensive Cancer Center
Tucson, Arizona, 85719
- Recruiting
Alliance Cancer Specialists, PC, Wynnewood
Wynnewood, Pennsylvania, 19096
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
China11 sites, 11 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Hunan Province Tumor Hospital
Changsha, 410013
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Anhui Provincial Cancer Hospital
Hefei, 230001
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, 210008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanghai East Hospital
Shanghai, 200120
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanghai GoBroad Cancer Hospital
Shanghai, 200131
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, 430030
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, 450008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Spain10 sites, 10 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Germans Trias i Pujol
Badalona, 08916
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital del Mar
Barcelona, 08003
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Duran i Reynals
Barcelona, 08908
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Clínica Universidad de Navarra - Madrid
Madrid, 28027
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Clínico San Carlos
Madrid, 28040
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Clínica Universidad de Navarra
Pamplona, 31008
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Virgen del Rocio
Seville, 41013
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Clinico De Valencia (INCLIVA)
Valencia, 46010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Japan9 sites, 9 recruiting
- Recruiting
Aichi Cancer Center Hospital
Aichi, Nagoya, 464-8681
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Okayama University Hospital
Okayama, Okayama, 700-8558
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
France6 sites, 5 recruiting
- Recruiting
INS Bergonie
Bordeaux, 33000
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
CTR Georges-François Leclerc
Dijon, 21079
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Completed
CTR Leon Berard
Lyon, 69373
- Recruiting
HOP Timone
Marseille, 13385
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP la Milétrie
Poitiers, 86000
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Germany6 sites, 5 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 12203
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Justus-Liebig Universität Gießen
Giessen, 35392
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Asklepios Kliniken GmbH & Co. KGaA
Hamburg, 22763
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universität Leipzig
Leipzig, 04103
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Completed
Universitätsklinikum Mannheim GmbH
Mannheim, 68167
- Recruiting
Klinikum rechts der Isar der Technischen Universität München
München, 81675
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Italy6 sites, 6 recruiting
- Recruiting
Az. Ospedaliere Umberto I di Ancona
Ancona, 60020
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Centro di riferimento Oncologico
Aviano (PN), 33081
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Istituto Scientifico Romagnolo
Meldola (FC), 47014
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
AOU Università degli Studi della Campania Luigi Vanvitelli
Naples, 80131
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Fondazione Policlinico Universitario Campus Bio-medico
Rome, 00128
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Australia5 sites, 5 recruiting
- Recruiting
Cancer Research South Australia
Adelaide, South Australia, 5000
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Macquarie University
Macquarie Park, New South Wales, 2109
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
GenesisCare North Shore
St Leonards, New South Wales, 2065
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
St John of God Subiaco Hospital
Subiaco, Western Australia, 6008
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Canada5 sites, 4 recruiting
- Recruiting
Cross Cancer Institute (University of Alberta)
Edmonton, Alberta, T6G 1Z2
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0A9
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Completed
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
BC Cancer Agency - Vancouver
Vancouver, British Columbia, V5Z 4E6
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Severance Hospital
Seoul, 03722
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Asan Medical Center
Seoul, 05505
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Samsung Medical Center
Seoul, 135-710
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
United Kingdom3 sites, 3 recruiting
- Recruiting
Ninewells Hospital & Medical School
Dundee, DD1 9SY
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Not yet recruiting
Hammersmith Hospital
London, W12 0HS
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
The Christie
Manchester, M20 4BX
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Belgium2 sites, 2 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Netherlands2 sites, 2 recruiting
- Recruiting
Nederlands Kanker Instituut
Amsterdam, 1066 CX
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
- Recruiting
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GL
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
Norway1 site, 1 recruiting
- Recruiting
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, N-0379
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
Puerto Rico1 site, 1 recruiting
- Recruiting
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935
Boehringer Ingelheim, 18336022368, unitedstates@bitrialsupport.com
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
Boehringer Ingelheim, 8001207344, singapore@bitrialsupport.com
About this study
Official title: 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.
- Conditions
- Solid Tumours
- Being tested
- Zongertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZongertinibDrug
Also called BI 1810631, Hernexeos®
Zongertinib
| Study group | Role | What they receive |
|---|---|---|
| Zongertinib treatment | Experimental | Not described Receives: Drug: Zongertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with objective response (OR)
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
Measured: Up to 51 months
Secondary outcomes (6)
Duration of objective response (DOR)
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.
Measured: Up to 51 months
Progression-Free Survival (PFS)
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.
Measured: Up to 51 months
Disease control (DC)
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.
Measured: Up to 51 months
Occurrence of treatment-emergent Adverse Events (AEs)
Measured: 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
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.
Measured: At baseline and up to 48 weeks
Overall survival (OS)
OR is defined as the time from start of treatment to death from any cause
Measured: Up to 51 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start11 Oct 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion29 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumoursStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581432
- Sponsor's protocol ID
- 1479-0009
- Other IDs
- 2023-510429-14-00, U1111-1302-3333, 2023
- Status last verified
- Oct 2026
- First submitted
- 30 Aug 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Schram AM, Park JJ, Italiano A, Kitano S, Guo Y, Li J, Bedard PL, van Marcke C, Ko R, Lunger L, Klotz DM, Hussain J, Maier D, Erzen D, Planchard D, Prenen H, Clay TD, Park JO, Kim HD, Hernando-Calvo A, Maruki Y, Ponz-Sarvise M, Dumbrava E. Beamion PANTUMOR-1: rationale and design of a Phase II trial of zongertinib in HER2-overexpressed/amplified or HER2-mutant solid tumors. Future Oncol. 2026 Mar;22(7):795-803. doi: 10.1080/14796694.2026.2637740. Epub 2026 Mar 4.
PubMed 41777164
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06581432
- Acronym / sponsor ID
- 1479-0009
- Conditions
- Solid Tumours
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 29 Dec 2028 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zongertinib treatment | Experimental | Drug: Zongertinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- Diagnosis of HER2-positive (overexpressed/amplified) metastatic breast cancer
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZongertinibAlso: BI 1810631, Hernexeos®Zongertinib | Drug | Zongertinib treatment |
Primary outcome
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
6 secondary outcomes
Duration of objective response (DOR)
Time frame: Up to 51 months
Progression-Free Survival (PFS)
Time frame: Up to 51 months
Disease control (DC)
Time frame: Up to 51 months
Occurrence of treatment-emergent Adverse Events (AEs)
Time frame: 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
Overall survival (OS)
Time frame: Up to 51 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 41777164Schram AM, Park JJ, Italiano A, Kitano S, Guo Y, Li J, Bedard PL, van Marcke C, Ko R, Lunger L, Klotz DM, Hussain J, Maier D, Erzen D, Planchard D, Prenen H, Clay TD, Park JO, Kim HD, Hernando-Calvo A, Maruki Y, Ponz-Sarvise M, Dumbrava E. Beamion PANTUMOR-1: rationale and design of a Phase II trial of zongertinib in HER2-overexpressed/amplified or HER2-mutant solid tumors. Future Oncol. 2026 Mar;22(7):795-803. doi: 10.1080/14796694.2026.2637740. Epub 2026 Mar 4.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
92 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zongertinib in people with Solid Tumours, run by Boehringer Ingelheim at 92 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in United States, China, Spain, Japan, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with objective response (OR) (time frame: Up to 51 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06581432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.