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
- Solid Tumours
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Boehringer Ingelheim
- Enrolment target
- 588
- Started
- 11 October 2024
- Main results due
- 30 November 2028
- Study sites
- 92
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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 sites(92)
Alaska Oncology and Hematology, LLC
Anchorage, Alaska, United States
Recruiting
University of Arizona Comprehensive Cancer Center
Tucson, Arizona, United States
Completed
Precision NextGen Oncology
Beverly Hills, California, United States
Recruiting
Scripps Cancer Center Torrey Pines
La Jolla, California, United States
Recruiting
Valkyrie Clinical Trials
Los Angeles, California, United States
Recruiting
Yale University School of Medicine
New Haven, Connecticut, United States
Recruiting
BRCR Global - Tamarac
Tamarac, Florida, United States
Recruiting
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Recruiting
Community MD Anderson Cancer Center - East Medical Oncology
Indianapolis, Indiana, United States
Recruiting
Maryland Oncology Hematology, Columbia
Columbia, Maryland, United States
Recruiting
Karmanos Cancer Institute
Detroit, Michigan, United States
Completed
Presbyterian Healthcare Services
Albuquerque, New Mexico, United States
Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Recruiting
Taylor Cancer Research Center
Maumee, Ohio, United States
Recruiting
Alliance Cancer Specialists, PC, Wynnewood
Wynnewood, Pennsylvania, United States
Recruiting
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States
Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
Texas Oncology - Plano West
Plano, Texas, United States
Recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Recruiting
Macquarie University
Macquarie Park, New South Wales, Australia
Recruiting
GenesisCare North Shore
St Leonards, New South Wales, Australia
Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Recruiting
Cancer Research South Australia
Adelaide, South Australia, Australia
Recruiting
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia
Recruiting
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Recruiting
Cross Cancer Institute (University of Alberta)
Edmonton, Alberta, Canada
Recruiting
BC Cancer Agency - Vancouver
Vancouver, British Columbia, Canada
Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Recruiting
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Completed
Peking University First Hospital
Beijing, China
Recruiting
Hunan Province Tumor Hospital
Changsha, China
Not yet recruiting
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, China
Recruiting
Anhui Provincial Cancer Hospital
Hefei, China
Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, China
Recruiting
Nanjing Drum Tower Hospital
Nanjing, China
Not yet recruiting
Shanghai East Hospital
Shanghai, China
Recruiting
Shanghai GoBroad Cancer Hospital
Shanghai, China
Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Recruiting
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, China
Not yet recruiting
Henan Cancer Hospital
Zhengzhou, China
Recruiting
INS Bergonie
Bordeaux, France
Recruiting
CTR Georges-François Leclerc
Dijon, France
Recruiting
CTR Leon Berard
Lyon, France
Completed
HOP Timone
Marseille, France
Recruiting
HOP la Milétrie
Poitiers, France
Recruiting
Institut Gustave Roussy
Villejuif, France
Recruiting
Charité - Universitätsmedizin Berlin
Berlin, Germany
Recruiting
Justus-Liebig Universität Gießen
Giessen, Germany
Recruiting
Asklepios Kliniken GmbH & Co. KGaA
Hamburg, Germany
Recruiting
Universität Leipzig
Leipzig, Germany
Recruiting
Universitätsklinikum Mannheim GmbH
Mannheim, Germany
Recruiting
Klinikum rechts der Isar der Technischen Universität München
München, Germany
Recruiting
Az. Ospedaliere Umberto I di Ancona
Ancona, Italy
Recruiting
Centro di riferimento Oncologico
Aviano (PN), Italy
Not yet recruiting
Istituto Scientifico Romagnolo
Meldola (FC), Italy
Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Recruiting
AOU Università degli Studi della Campania Luigi Vanvitelli
Naples, Italy
Recruiting
Showing 60 of 92 sites — filter to narrow it down. 79 of the 92 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06581432. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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