Beamion BCGC-1: A Phase Ib dose escalation and Phase II dose optimization, randomized, open-label, multicenter trial of oral zongertinib (BI 1810631) alone or in combination with other agents for the treatment of patients with advanced HER2+metastatic breast cancer (mBC), metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC), or metastatic colorectal cancer (mCRC)
Date de révision : 21/05/2026
33 participants
Homme Femme
A partir de 18 ans
Critères :
Critères d'inclusion :
- 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)
- Cohorts A to K and Cohort O: Documented HER2+ mBC or mGEAC
- Cohorts L (L-ext), M, and N (mCRC): Documented HER2 overexpression/amplification
- For dose optimization and justification (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible, collected through archival tissue
- History of prior treatment lines in palliative setting: - For cohorts A, B, C, D, E, F, G, H, I, I-ext, J, J-ext, K and O documented investigator assessed progression; - For cohorts L, L-ext, M and N documented progression or recurrence of disease during or following their latest line of therapy.
- 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
Critères d'exclusion :
- 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, personal or family history of long QT syndrome or unexplained sudden death under 40 years-of-age
- Ejection fraction <50% or the lower limit of normal of the institutional standard within 28 days prior to randomization
- 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
Lieux et contacts
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Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".