Beamion BCGC-1: Finding a Safe Dose of Zongertinib for HER2+ Cancer
Phase 1/2
768
about 4.6 years
18+
28 sites in AZ, CA, CT +14
What this study is about
This trial is testing different doses of zongertinib, either alone or with other treatments, to see if it can help people with HER2+ cancer that has spread. The goal is to find the best dose of zongertinib that people can tolerate when combined with trastuzumab deruxtecan, trastuzumab emtansine, zanidatamab, mFOLFOX6, or trastuzumab and capecitabine.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Capecitabine
- 2.Take Trastuzumab
- 3.Take Trastuzumab deruxtecan
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
capecitabine, trastuzumab (Monoclonal antibody; targets HER2 protein on cancer cells), trastuzumab deruxtecan, trastuzumab emtansine, kinase inhibitor, zanidatamab
oral (Oral Tablet), injection, intravenous, infusion
Primary: Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period, Dose optimization and justification (Phase II): Objective response (OR)
Secondary: Dose escalation (Phase Ib): Maximum measured concentration of zongertinib (at steady state) (Cmax,(ss)), Dose escalation (Phase Ib): Objective response (OR), Dose optimization and justification (Phase II): Maximum measured concentration (at steady state) (Cmax,(ss)), Dose optimization and justification (Phase II): Occurrence of treatment-emergent AEs leading to zongertinib (BI 1810631) dose reduction during the on-treatment period, Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - EORTC IL19, Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - EORTC IL46, Dose optimization and justification (Phase II): Patient-reported outcome (PRO) - PRO-CTCAE, Dose optimization and justification (Phase II): Progression-free survival (PFS)
Oncology