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
About this study
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.
Based on ClinicalTrials.gov records.
What participants do
- 1.Take Capecitabine
- 2.Take Trastuzumab
- 3.Take Trastuzumab deruxtecan
- +3 more
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
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