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Testing Zongertinib for 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

Phase 2 Interventional Boehringer Ingelheim · NCT06581432

This study is testing if a new drug called zongertinib can help adults with advanced cancers that have specific HER2 changes, especially after other treatments haven't worked.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment430 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Drugs / interventionszongertinib
Locations88 sites (Anchorage, Alaska and 87 other locations)
Trial IDNCT06581432 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of zongertinib in treating adults with advanced cancers that have HER2 alterations, particularly after previous treatments have failed. Participants, aged 18 and older, will be grouped based on their specific type of advanced cancer and HER2 alteration. Each participant will take a daily dose of zongertinib and will be monitored regularly for tumor size and health status. The goal is to determine if zongertinib can provide therapeutic benefits for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and over with advanced solid tumors exhibiting HER2 overexpression, amplification, or known activating mutations.

Not a fit: Patients without HER2 alterations or those who have not previously received treatment for their advanced cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new option for patients with advanced cancers that have not responded to prior therapies.

How similar studies have performed: Other studies targeting HER2 alterations have shown promise, indicating that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
inclusion criteria:

* 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.

Further inclusion criteria apply.

exclusion criteria:

* 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
* Not completely recovered from major surgery (major according to the investigator's assessment) performed prior to screening or planned within 6 months after screening, e.g. hip replacement Further exclusion criteria apply.

Where this trial is running

Anchorage, Alaska and 87 other locations

+38 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid Tumours
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.