Beamion PANTUMOR-1: A Phase II, multicentre, multicohort, open-label trial to evaluate the efficacy and safety of oral zongertinib (BI 1810631) for the treatment of selected HER2-mutated or overexpressed/amplified solid tumours

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510429-14-00

Acronym

1479-0009

Enrollment

108

Registered

2024-09-09

Start date

2024-10-22

Completion date

Unknown

Last updated

2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-mutated or overexpressed/amplified solid tumours

Brief summary

Proportion of patients with objective response (OR)

Detailed description

Duration of objective response (DOR), Progression free survival (PFS), Disease control (DC), Overall survival (OS), Occurrence of treatment-emergent adverse events (AEs), Change from baseline to Week 48 or PD by central independent review, if earlier, in the European Organisation for Research and Treatment of Cancer, (EORTC QLQ-C30)

Interventions

DRUGBI 1810631

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of patients with objective response (OR)	—

Secondary

Measure	Time frame
Duration of objective response (DOR), Progression free survival (PFS), Disease control (DC), Overall survival (OS), Occurrence of treatment-emergent adverse events (AEs), Change from baseline to Week 48 or PD by central independent review, if earlier, in the European Organisation for Research and Treatment of Cancer, (EORTC QLQ-C30)	—

Countries

Belgium, France, Germany, Italy, Netherlands, Norway, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026