protocolSection identificationModule nctId: NCT06324357, orgStudyIdInfo id: 1479-0012, briefTitle: Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2027-02-22, completionDateStruct date: 2028-08-21, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd) or with trastuzumab emtansine (T-DM1). Another purpose is to check whether zongertinib in combination with T-DXd or with T-DM1 can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow.The study is split into treatment cycles. All study participants are treated with zongertinib in combination with T-DXd or with T-DM1. This study has 2 parts. In Part 1, participants receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group.During the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with T-DXd or with T-DM1. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects., conditionsModule conditions: Metastatic Breast Cancer, conditions: Metastatic Gastric Adenocarcinoma, conditions: Gastroesophageal Junction Adenocarcinoma, conditions: Esophageal Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Zongertinib, interventions name: Trastuzumab deruxtecan, interventions name: Trastuzumab emtansine, outcomesModule primaryOutcomes measure: Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period, primaryOutcomes measure: Dose optimization (Phase II): Objective response (OR), secondaryOutcomes measure: Dose escalation (Phase Ib): Objective response (OR), secondaryOutcomes measure: Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) during the entire treatment period, secondaryOutcomes measure: Dose escalation (Phase Ib): Maximum measured concentration of the analyte in plasma (Cmax), secondaryOutcomes measure: Dose escalation (Phase Ib): Area under the concentration-time curve of the analyte in plasma from 0 to t2 (AUC0-t2), secondaryOutcomes measure: Dose optimization (Phase II): Progression-free survival (PFS), secondaryOutcomes measure: Dose optimization (Phase II): Disease control (DC), secondaryOutcomes measure: Dose optimization (Phase II): Occurrence of treatment-emergent AEs leading to zongertinib (BI 1810631) dose reduction during the on-treatment period, secondaryOutcomes measure: Dose optimization (Phase II): Maximum measured concentration of the analyte in plasma (Cmax), secondaryOutcomes measure: Dose escalation (Phase II): Area under the concentration-time curve of the analyte in plasma from 0 to t2 (AUC0-t2), secondaryOutcomes measure: Dose optimization (Phase II): Patient-reported outcome (PRO) - PRO-CTCAE, secondaryOutcomes measure: Dose optimization (Phase II): Patient-reported outcome (PRO) - EORTC IL46, secondaryOutcomes measure: Dose optimization (Phase II): Patient-reported outcome (PRO) - EORTC IL19, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False