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Brightline-2: A Phase IIa/IIb, open-label, single-arm, multi-centre trial of BI 907828 for treatment of patients with locally advanced / metastatic, MDM2 amplified, TP53 wild-type biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, or other selected solid tumours

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506369-79-00
Acronym
1403-0011
Enrollment
38
Registered
2023-10-30
Start date
2022-11-30
Completion date
2025-06-25
Last updated
2025-06-02

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

Conditions

Pancreatic ductal adenocarcinoma, Lung adenocarcinoma, Biliary tract adenocarcinoma, Urothelial bladder cancer

Brief summary

Objective response (OR) based on central independent review

Detailed description

Duration of objective response (DOR) based on central independent review, Progression-free survival (PFS) based on central independent review, Overall survival (OS), Disease control (DC) based on central independent review, Occurrence of treatment-emergent adverse events (AEs) during the on-treatment period., Occurrence of treatment-emergent AEs leading to trial drug discontinuation during the on-treatment period., Change from baseline in EORTC QLQ-C30 physical functioning domain score, Change from baseline in EORTC QLQ-C30 fatigue domain score, Change from baseline in EORTC QLQ-C30 role functioning domain score, Change from baseline in EORTC QLQ-BIL21 tiredness domain score

Interventions

DRUGBI 907828

Sponsors

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim RCV GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Objective response (OR) based on central independent review—

Secondary

MeasureTime frame
Duration of objective response (DOR) based on central independent review, Progression-free survival (PFS) based on central independent review, Overall survival (OS), Disease control (DC) based on central independent review, Occurrence of treatment-emergent adverse events (AEs) during the on-treatment period., Occurrence of treatment-emergent AEs leading to trial drug discontinuation during the on-treatment period., Change from baseline in EORTC QLQ-C30 physical functioning domain score, Change from baseline in EORTC QLQ-C30 fatigue domain score, Change from baseline in EORTC QLQ-C30 role functioning domain score, Change from baseline in EORTC QLQ-BIL21 tiredness domain score—

Countries

Austria, Belgium, France, Germany, Spain

Outcome results

None listed

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