Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
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
3 other identifiers
interventional
430
16 countries
88
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2024
Typical duration for phase_2
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2024
CompletedFirst Posted
Study publicly available on registry
September 3, 2024
CompletedStudy Start
First participant enrolled
October 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 29, 2028
June 9, 2026
June 1, 2026
3.2 years
August 30, 2024
June 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Up to 51 months
Secondary Outcomes (6)
Duration of objective response (DOR)
Up to 51 months
Progression-Free Survival (PFS)
Up to 51 months
Disease control (DC)
Up to 51 months
Occurrence of treatment-emergent Adverse Events (AEs)
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
At baseline and up to 48 weeks
- +1 more secondary outcomes
Study Arms (1)
Zongertinib treatment
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Patients ≥18 years old 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).
- Documented (previously established by local testing) Human epidermal growth factor receptor 2 (HER2) status of:
- HER2 amplification
- Known activating HER2 mutations
- Availability and willingness to provide a sample of archival formalin-fixed paraffin embedded (FFPE) tumour tissue material
- Patient with histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumour who has had at least one prior line of therapy for metastatic disease. 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.
You may not qualify if:
- Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC)
- Previous or concomitant malignancies other than the 1 treated in this trial within the previous 3 years except:
- effectively treated non-melanoma skin cancers
- effectively treated carcinoma in situ of the cervix
- effectively treated ductal carcinoma in situ of the breast
- localised prostate cancer on watchful waiting or active surveillance
- other effectively treated malignancy that is considered cured by local treatment.
- Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (88)
Alaska Oncology and Hematology, LLC
Anchorage, Alaska, 99508, United States
University of Arizona Comprehensive Cancer Center
Tucson, Arizona, 85719, United States
Precision NextGen Oncology
Beverly Hills, California, 90212, United States
Scripps Cancer Center Torrey Pines
La Jolla, California, 92037, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
Yale University School of Medicine
New Haven, Connecticut, 06511, United States
BRCR Global
Tamarac, Florida, 33321, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
Community MD Anderson Cancer Center - East Medical Oncology
Indianapolis, Indiana, 46219, United States
Maryland Oncology Hematology, Columbia
Columbia, Maryland, 21044, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Presbyterian Healthcare Services
Albuquerque, New Mexico, 87110, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Taylor Cancer Research Center
Maumee, Ohio, 43537, United States
Alliance Cancer Specialists, PC, Wynnewood
Wynnewood, Pennsylvania, 19096, United States
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, 75230, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology - Plano West
Plano, Texas, 75093, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Macquarie University
Macquarie Park, New South Wales, 2109, Australia
GenesisCare North Shore
St Leonards, New South Wales, 2065, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, 6008, Australia
Cancer Research South Australia
Adelaide, Australia
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Edegem - UNIV UZ Antwerpen
Edegem, 2650, Belgium
Cross Cancer Institute (University of Alberta)
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer Agency - Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0A9, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1, Canada
Peking University First Hospital
Beijing, 100034, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016, China
Anhui Provincial Cancer Hospital
Hefei, 230001, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Shanghai East Hospital
Shanghai, 200120, China
Shanghai GoBroad Cancer Hospital
Shanghai, 200131, China
Wuhan Union Hospital
Wuhan, 430022, China
Henan Cancer Hospital
Zhengzhou, 450008, China
INS Bergonie
Bordeaux, 33000, France
CTR Georges-François Leclerc
Dijon, 21079, France
CTR Leon Berard
Lyon, 69373, France
HOP Timone
Marseille, 13385, France
HOP la Milétrie
Poitiers, 86000, France
Institut Gustave Roussy
Villejuif, 94805, France
Charité - Universitätsmedizin Berlin
Berlin, 12203, Germany
Justus-Liebig Universität Gießen
Giessen, 35392, Germany
Asklepios Kliniken GmbH & Co. KGaA
Hamburg, 22763, Germany
Universität Leipzig
Leipzig, 04103, Germany
Universitätsklinikum Mannheim GmbH
Mannheim, 68167, Germany
Klinikum rechts der Isar der Technischen Universität München
München, 81675, Germany
Az. Ospedaliere Umberto I di Ancona
Ancona, 60020, Italy
Centro di riferimento Oncologico
Aviano (PN), 33081, Italy
Istituto Scientifico Romagnolo
Meldola (FC), 47014, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
AOU Università degli Studi della Campania Luigi Vanvitelli
Naples, 80131, Italy
Fondazione Policlinico Universitario Campus Bio-medico
Rome, 00128, Italy
Aichi Cancer Center Hospital
Aichi, Nagoya, 464-8681, Japan
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648, Japan
Okayama University Hospital
Okayama, Okayama, 700-8558, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777, Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045, Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550, Japan
Nederlands Kanker Instituut
Amsterdam, 1066 CX, Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GL, Netherlands
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, N-0379, Norway
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935, Puerto Rico
National Cancer Centre Singapore
Singapore, 168583, Singapore
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital Germans Trias i Pujol
Badalona, 08916, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Duran i Reynals
Barcelona, 08908, Spain
Clínica Universidad de Navarra - Madrid
Madrid, 28027, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Clínica Universidad de Navarra
Pamplona, 31008, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Hospital Clinico De Valencia (INCLIVA)
Valencia, 46010, Spain
Ninewells Hospital & Medical School
Dundee, DD1 9SY, United Kingdom
The Christie Hospital
Manchester, M20 4BX, United Kingdom
Related Publications (1)
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.
PMID: 41777164DERIVED
Related Links
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2024
First Posted
September 3, 2024
Study Start
October 11, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 29, 2028
Last Updated
June 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.