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Beamion PANTUMOR-1: Zongertinib for Advanced Cancers with HER2 Alterations

This study, called Beamion PANTUMOR-1, is for adults aged 18 and over with advanced cancers that have not responded to previous treatments. You may be able to join if your cancer has specific changes called HER2 alterations, which can cause cancer. The study is testing if a medicine called zongertinib, which works by blocking HER2, can help. Participants will be grouped based on their cancer type, HER2 alteration, and the dose of zongertinib they receive. You will take one of two different doses of zongertinib daily and can continue treatment as long as it helps and you tolerate it. The main goal is to see how many patients experience a positive response to the treatment, measured for up to 51 months. The current status of this study is unclear.

Study design
This is an interventional study for people with advanced solid tumors. It plans to enroll 588 participants.
What's involved
You will take zongertinib daily and visit the study site regularly. You can continue treatment as long as you benefit and tolerate it.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, objective response, is measured for up to 51 months.

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NCT06581432

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Boehringer Ingelheim
~588 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Zongertinib

At a glance

Recruiting sites
75 of 89 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients with objective response (OR)
Measured over Up to 51 months

Conditions

Solid Tumours

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Solid NeoplasmERBB2 Gene

Where it's being run

89 sites across 36 states
Spain10
Japan9
China8
France6
Germany6
Italy6
South Korea4
California3

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Proportion of patients with objective response (OR)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