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

RecruitingPhase 2Ages 18 Years - anyAllBoehringer Ingelheim
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In plain words

What the trial is, and whether it could suit you

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 t

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: * Patients aged โ‰ฅ18 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 โ‰ฅ1 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 * 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.
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What it tests

  • Zongertinib
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Where

92 sites
Alaska Oncology and Hematology, LLC
Anchorage, United States
University of Arizona Comprehensive Cancer Center
Tucson, United States
Precision NextGen Oncology
Beverly Hills, United States
Scripps Cancer Center Torrey Pines
La Jolla, United States
Valkyrie Clinical Trials
Los Angeles, United States
Yale University School of Medicine
New Haven, United States
BRCR Global - Tamarac
Tamarac, United States
Illinois Cancer Specialists
Arlington Heights, United States

โ€ฆand 84 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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