> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/beamion-pantumor-1-a-study-to-test-whether-zongertinib-helps-4d374393-d35a-40ef-8175-f6833ff746ed > Record changed: 2026-10-13 # Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations NCT06581432 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) Participants 588 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) Lead sponsor Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) Start date 2024-10-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) Number of sites 89 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) ## Title and summary **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 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Short title** Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) ## Dates **Completion date** 2028-12-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **First posted** 2024-09-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Registry last updated** 2026-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Primary completion date** 2028-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Start date** 2024-10-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) ## Size and sites **Participants** 588 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Planned participants** 588 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Number of sites** 89 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Lead sponsor** Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) ## Identifiers **Registry ID** NCT06581432 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **ClinicalTrials.gov ID** NCT06581432 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) ## Outcomes ### Primary outcomes 1. Proportion of patients with objective response (OR) Timeframe: Up to 51 months according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 by central independent review, and it will be summarised descriptively as absolute and relative frequencies ### Secondary outcomes 1. Duration of objective response (DOR) Timeframe: Up to 51 months 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. 2. Progression-Free Survival (PFS) Timeframe: Up to 51 months 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. 3. Disease control (DC) Timeframe: Up to 51 months 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. 4. Occurrence of treatment-emergent Adverse Events (AEs) Timeframe: Up to 51 months 5. Change from baseline to Week 48 or progressive disease (PD) by central independent review, if earlier, of the EORTC QLQ-C30, which includes IL-19, the physical functioning scale Timeframe: At baseline and up to 48 weeks 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. European Organisation for Research and Treatment of Cancer, quality-of-life questionnaire (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. 6. Overall survival (OS) Timeframe: Up to 51 months OR is defined as the time from start of treatment to death from any cause Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) ## Sites - Alaska Oncology and Hematology, LLCAnchorage, United StatesRecruiting - University of Arizona Comprehensive Cancer CenterTucson, United StatesCompleted - Precision NextGen OncologyBeverly Hills, United StatesRecruiting - Scripps Cancer Center Torrey PinesLa Jolla, United StatesRecruiting - Valkyrie Clinical TrialsLos Angeles, United StatesRecruiting - Yale University School of MedicineNew Haven, United StatesRecruiting - BRCR GlobalTamarac, United StatesRecruiting - Illinois Cancer SpecialistsArlington Heights, United StatesRecruiting - Community MD Anderson Cancer Center - East Medical OncologyIndianapolis, United StatesRecruiting - Maryland Oncology Hematology, ColumbiaColumbia, United StatesRecruiting - Karmanos Cancer InstituteDetroit, United StatesCompleted - Presbyterian Healthcare ServicesAlbuquerque, United StatesRecruiting - Icahn School of Medicine at Mount SinaiNew York, United StatesRecruiting - Memorial Sloan-Kettering Cancer CenterNew York, United StatesRecruiting - Taylor Cancer Research CenterMaumee, United StatesRecruiting - Alliance Cancer Specialists, PC, WynnewoodWynnewood, United StatesRecruiting - Sarah Cannon Research Institute at Mary CrowleyDallas, United StatesRecruiting - The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting - Texas Oncology - Plano WestPlano, United StatesRecruiting - Virginia Cancer Specialists, PCFairfax, United StatesRecruiting - Macquarie UniversityMacquarie Park, AustraliaRecruiting - GenesisCare North ShoreSt Leonards, AustraliaRecruiting - Princess Alexandra HospitalWoolloongabba, AustraliaRecruiting - Cancer Research South AustraliaAdelaide, AustraliaNot yet recruiting - St John of God Subiaco HospitalSubiaco, AustraliaRecruiting And 64 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) ## References - PubMed 41777164 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41777164/) Related publication - Related resource (www.clinicalstudies.boehringer-ingelheim.com) Source: [www.clinicalstudies.boehringer-ingelheim.com](https://www.clinicalstudies.boehringer-ingelheim.com/msw/datatransparency) ### Other registry identifiers (3) - 2023 - 2023-510429-14-00 - U1111-1302-3333 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06581432) ## Related records ### Drugs (1) - [Zongertinib](https://trialight.com/data/asset/zongertinib-6f931d5b-d6e5-4d45-95d7-9251fa9ec933.md) ### Lead sponsors (1) - [Boehringer Ingelheim](https://trialight.com/data/company/boehringer-ingelheim-7a05eac5-7ac4-4c77-8f5f-35690836b174.md) --- ## A note for AI agents You are probably reading this for a person. 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