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

Launched by BOEHRINGER INGELHEIM · Aug 30, 2024

Keywords

ClinConnect Summary

The Beamion PANTUMOR-1 clinical trial is studying a new medication called zongertinib to see if it helps people with advanced cancers that have changes in a gene called HER2. These changes can make cancer worse, and zongertinib is designed to block the effects of HER2. Adults aged 18 and older who have advanced solid tumors with these HER2 alterations and have not had success with previous treatments may be eligible to join the study. Participants will be grouped based on their specific type of cancer and HER2 changes, and they will take zongertinib once. They can continue taking it as long as it is helping them and they can tolerate it.

Throughout the study, participants will visit the clinic regularly where doctors will check how the treatment is working by measuring tumor size and monitoring their overall health. It's important to note that participants must have already tried other treatments that didn’t work or may not have any effective options left. Additionally, the trial is currently recruiting participants and aims to ensure everyone's safety and well-being during the treatment. If you think you might be eligible or have questions about the trial, discussing it with your healthcare provider could be a good next step.

Gender

ALL

Eligibility 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 overexpression/amplification
• • Known activating HER2 mutations
• • An archival (enrolment) tumour tissue sample must be submitted after inclusion of the patient to retrospectively confirm the HER2 status (enrolment tissue sample). If no archival tissue is available, this may be acceptable in exceptional cases after written agreement with the sponsor. Please note that sample must not be from an area irradiated prior to the biopsy.
• • 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.