Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-29 @ 6:07 AM
Study NCT ID:
NCT06581432
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2024-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 430}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2024-08-30', 'studyFirstSubmitQcDate': '2024-08-30', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with objective response (OR)', 'timeFrame': 'Up to 51 months', 'description': 'Objective response (OR) is defined as the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as assessed by central independent review, from the date of treatment start until the earliest date of progressive disease (PD), death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, or trial treatment discontinuation.'}], 'secondaryOutcomes': [{'measure': 'Duration of objective response (DOR)', 'timeFrame': 'Up to 51 months', 'description': 'Duration of objective response (DOR) is defined as the time from first documented Objective response (OR) according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed OR, assessed by central independent review.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to 51 months', 'description': 'PFS is defined as the time from treatment start until the earliest date of tumour progression according to RECIST 1.1 assessed by central independent review, or death from any cause, whichever occurs first.'}, {'measure': 'Disease control (DC)', 'timeFrame': 'Up to 51 months', 'description': 'Disease control (DC) is defined as best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) where BOR is defined according to RECIST 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, or treatment discontinuation, as assessed by central independent review.'}, {'measure': 'Occurrence of treatment-emergent Adverse Events (AEs)', 'timeFrame': 'Up to 51 months'}, {'measure': 'Change from baseline to Week 48 or progressive disease (PD) by central independent review, if earlier, in the European Organisation for Research and Treatment of Cancer, quality-of-life questionnaire (EORTC QLQ-C30)', 'timeFrame': 'At baseline and up to 48 weeks', 'description': 'QLQ-C30 incorporates both multi-items scales and single-item measures. These include 1 global health status/QoL scale, 5 functional scales, 3 symptoms scales and 6 single items to assess dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. EORTC QLQ-C30 does not produce a single overall summary score by default. Scores can be reported via domain-specific scores or summary score (since 2016) ranging from 0 to 100 with higher scores representing a better QoL.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 51 months', 'description': 'OR is defined as the time from start of treatment to death from any cause'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumours']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "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.\n\nParticipants are put into 13 groups based on the type of advanced cancer and the type of HER2 alterations they have. All participants take one dose of zongertinib each day. Participants can continue the treatment as long as they benefit from it and can tolerate it.\n\nParticipants 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 the body. During all the visits, the doctors check participants' health and take note of any unwanted effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "inclusion criteria:\n\n* 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.\n* 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).\n* Documented (previously established by local testing) Human epidermal growth factor receptor 2 (HER2) status of:\n\n * HER2 overexpression/amplification\n * Known activating HER2 mutations\n* Availability and willingness to provide a sample of archival formalin-fixed paraffin embedded (FFPE) tumour tissue material\n* 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.\n\nFurther inclusion criteria apply.\n\nexclusion criteria:\n\n* Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC) (except where there is co-existing presence of HER2 overexpression / amplification)\n* Previous or concomitant malignancies other than the 1 treated in this trial within the previous 3 years except:\n\n * effectively treated non-melanoma skin cancers\n * effectively treated carcinoma in situ of the cervix\n * effectively treated ductal carcinoma in situ of the breast\n * localised prostate cancer on watchful waiting or active surveillance\n * other effectively treated malignancy that is considered cured by local treatment.\n* 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\n* 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."}, 'identificationModule': {'nctId': 'NCT06581432', 'briefTitle': 'Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '1479-0009'}, 'secondaryIdInfos': [{'id': '2023-510429-14-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': 'U1111-1302-3333', 'type': 'REGISTRY', 'domain': 'WHO International Clinical Trials Registry Platform (ICTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zongertinib treatment', 'interventionNames': ['Drug: Zongertinib']}], 'interventions': [{'name': 'Zongertinib', 'type': 'DRUG', 'otherNames': ['BI 1810631, Hernexeos®'], 'description': 'Zongertinib', 'armGroupLabels': ['Zongertinib treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Alaska Oncology and Hematology, LLC', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'University of Arizona Comprehensive Cancer 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'phone': '1-800-243-0127'}]}, 'ipdSharingStatementModule': {'url': 'https://www.mystudywindow.com/msw/datasharing', 'timeFrame': 'One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.', 'ipdSharing': 'YES', 'description': 'Once the criteria in section \'time frame\' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.', 'accessCriteria': "For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}