Beamion BCGC-1: A Phase Ib dose escalation and Phase II dose optimization, randomized, open-label, multicenter trial of oral zongertinib (BI 1810631) in combination with intravenous trastuzumab deruxtecan (T-DXd) or in combination with intravenous trastuzumab emtansine (T-DM1) for treatment of patients with advanced HER2+ metastatic breast cancer (mBC) and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC) - 1479-0012

Boehringer Ingelheim International GmbH0 个研究点目标入组 224 人开始时间: 2024年3月7日最近更新: 2024年7月22日

适应症

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•Patients =18 years of age 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 HER2+ mBC or mGEAC, For dose optimization (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible, collected through archival tissue, Documented investigator assessed progression, Presence of at least one measurable lesion according to RECIST 1.1, Eastern Cooperative Oncology Group (ECOG) score of 0 or 1, Adequate organ function based on laboratory values

•Mean resting corrected QT interval (QTcF) >470 msec., Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval, Ejection fraction <50% or the lower limit of normal of the institutional standard, History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening

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