Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers
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.
| Condition(s) | Solid Tumours |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Boehringer Ingelheim |
| Locations | Anchorage, Alaska, United States; Tucson, Arizona, United States; Beverly Hills, California, United States; La Jolla, California, United States; Los Angeles, California, United States; New Haven, Connecticut, United States (+82 more sites) |
| Start date | 2024-10-11 |
| NCT ID | NCT06581432 |
| Official listing | https://clinicaltrials.gov/study/NCT06581432 |