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Clinical trial to find an appropriate dose of zongertinib in combination with trastuzumab deruxtecan or trastuzumab emtansine, and to test whether it helps people with different types of HER2 cancer that has spread

THE PRIMARY OBJECTIVE IS TO CHARACTERIZE THE SAFETY, TOLERABILITY AND DOSE-TOXICITY CURVE OF ZONGERTINIB IN COMBINATION WITH T-DXD OR IN COMBINATION WITH T-DM1 IN PATIENTS WITH HER2 METASTATIC BREAST CANCER (MBC) OR METASTATIC GASTRIC OR GASTROESOPHAGEAL ADENOCARCINOMA (MGEAC) BY EVALUATING ESCALATING DOSE LEVELS WITH OVERDOSE MONITORING TO ACHIEVE THE PRIMARY OBJECTIVE OF DETERMINING MAXIMUM TOLERATED DOSES (MTDS) AND/OR DOSES FOR FUTURE DEVELOPMENT.

Imagen del Dr. Ignacio Matos García, especialista en Oncología Médica de la Clínica Universidad de Navarra
Dr. Ignacio Matos García [SP] Curriculum
Specialist Medical Oncology Department
Madrid headquarters
Cancer Center
Gastrointestinal Cancer Area
Status
In recruitment
headquarters
Pamplona/Madrid

Technical Summary

  • PHASE IB DOSE-ESCALATION AND PHASE II DOSE-OPTIMIZATION RANDOMIZED TRIAL, MULTICENTER, OPEN-LABEL TRIAL TO EVALUATE ZONGERTINIB (BI 1810631) ORALLY IN COMBINATION WITH TRASTUZUMAB DERUXTECAN (T-DXD) INTRAVENOUSLY OR IN COMBINATION WITH TRASTUZUMAB EMTANSINE (T-DM1) INTRAVENOUSLY FOR THE TREATMENT OF PATIENTS WITH ADVANCED HER2 METASTATIC BREAST CANCER (MBC) AND METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA (MGJAC).
  • Code EudraCT: 2023-509566-38-00
  • Protocol number: 1479-0012
  • Promoter: Boehringer Ingelheim España, S.A.
  • Molecule/Drug: Zongertinib / Trastuzumab deruxtecán / Trastuzumab emtansina
  • Link to Clinical Trials

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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Information offered by the Spanish Registry of Clinical Studies

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