A multicenter, randomized, open-label, Phase Ib dose-escalation and Phase II dose-optimization study of oral zongertinib (BI 1810631) alone or in combination with other agents for the treatment of patients with advanced HER2-positive metastatic breast cancer (mBC) and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC).
Principal Investigator
Dott.ssa Virginia Quarà
Contact Information for Access
Phase
FASE II
Status
IN ATTIVAZIONE
Objective of the study
The primary objective of the dose optimization phase is to evaluate the antitumor activity of Zongertinib (BI 1810631) in combination with T‑DXd or in combination with T‑DM1, in order to support the selection of the most appropriate doses for subsequent clinical development.
The primary endpoint is the proportion of patients achieving an objective response (OR) according to RECIST version 1.1 criteria, as assessed by the investigator.
Metastatic breast cancer and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC).
ClinicalTrials.gov ID NCT06324357
Sponsor: Boehringer Ingelheim
Pathologies
Breast Cancer , Gastrointestinal tumor (GI tumor)
Medication
Oral zongertinib (BI 1810631) alone or in combination with other standard therapeutic agents.
Who is eligible to participate in the study?
Patients who are 18 years of age or older and who meet the study’s eligibility criteria may participate in this study.
Patients with advanced HER2-positive metastatic breast cancer (mBC) who have previously received treatment with trastuzumab, pertuzumab, and a taxane, or trastuzumab deruxtecan;
Patients with metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC) who have previously received treatment with trastuzumab and chemotherapy with or without pembrolizumab.
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