BI 907828

DRUG9 trials

Sponsors

Boehringer Ingelheim International GmbH, Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim RCV GmbH & Co. KG, Institut Bergonie, Institut Bergonie, Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim

Conditions

Adult patients with locally advanced/metastatic solid tumorsAdvanced dedifferentiated liposarcomaBiliary tract adenocarcinomaLung adenocarcinomaNeoplasmsPancreatic ductal adenocarcinomaSolid TumorsSolid tumours

Phase 1

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors)

CompletedNCT03449381

Boehringer IngelheimNeoplasms

Start: 2018-06-20End: 2025-11-13Updated: 2026-03-31

A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab)

CompletedNCT03964233

Boehringer IngelheimNeoplasms

Start: 2019-06-20End: 2026-02-06Updated: 2026-02-18

A Study in People With Advanced Cancer to Test Whether the Amount of BI 907828 in the Blood is Influenced by Taking an OATP Inhibitor or a CYP3 Inhibitor

CompletedNCT05372367

Boehringer IngelheimSolid Tumors

Start: 2022-08-11End: 2025-04-29Updated: 2026-02-03

A Study in People With Advanced Cancer to Test How BI 907828 is Processed in the Body

CompletedNCT05613036

Boehringer IngelheimSolid Tumors

Start: 2023-01-03End: 2025-01-13Updated: 2025-01-22

Phase 2

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

CompletedCTIS2023-506369-79-00

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim RCV GmbH & Co. KGBiliary tract adenocarcinoma, Lung adenocarcinoma, Pancreatic ductal adenocarcinoma +1

Start: 2022-11-30End: 2025-06-25Target: 38Updated: 2025-06-02

EMPIRE : Targeting MDM2 and PD1 in tumors with tertiary lymphoid structures

CompletedCTIS2023-506823-28-00

Institut Bergonie, Institut BergonieAdult patients with locally advanced/metastatic solid tumors

Start: 2024-06-14End: 2024-07-01Target: 120Updated: 2024-06-14

Brightline-1: A Phase II/III, randomized, open-label, multi-center study of brigimadlin (BI 907828) compared to doxorubicin as first line treatment of patients with advanced dedifferentiated liposarcoma

CompletedCTIS2024-511361-11-00

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.Advanced dedifferentiated liposarcoma

Start: 2022-03-25End: 2025-11-21Target: 209Updated: 2025-07-04

A Phase II, single-arm, open-label, long-term safety rollover trial of oral brigimadlin in patients with solid tumours

RecruitingCTIS2024-514177-21-00

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.Solid tumours

Start: 2024-12-02Target: 24Updated: 2025-07-01

Phase 3

Brightline-4: A Phase III open-label, single-arm, multi-center study to assess the safety and efficacy of brigimadlin (BI 907828) treatment in patients with treatment-naïve or pre-treated advanced dedifferentiated liposarcoma

CompletedCTIS2023-504522-19-00

Boehringer Ingelheim International GmbHdedifferentiated liposarcoma

End: 2024-12-11Target: 70Updated: 2024-12-10

Related Papers

Discovery and Characterization of Brigimadlin, a Novel and Highly Potent MDM2–p53 Antagonist Suitable for Intermittent Dose Schedules

Molecular Cancer Therapeutics2024-09-119 citations

Proteomic analysis in patients with dedifferentiated liposarcoma (DDLPS) in a phase Ia/Ib study of the MDM2–p53 antagonist brigimadlin.

Journal of Clinical Oncology2024-06-01

Treatment of patients with dedifferentiated liposarcoma (DDLPS) with the MDM2–p53 antagonist brigimadlin and p53 function: A longitudinal analysis of circulating microRNAs (miRNAs) in a first-in-human phase Ia/Ib study.

Journal of Clinical Oncology2024-06-01

Abstract CT288: Brightline-4: A phase 3 open-label, single-arm, multicenter study to assess the safety and efficacy of brigimadlin (BI 907828) treatment in patients with treatment-naïve or pretreated advanced dedifferentiated liposarcoma

Cancer Research2024-04-051 citations

Ezabenlimab (BI 754091), an anti-PD-1 antibody, in patients with advanced solid tumours

Cancer Immunology Immunotherapy2024-03-303 citations

56O A phase Ia/Ib study of the MDM2-p53 antagonist brigimadlin (BI 907828): Safety and efficacy in patients with dedifferentiated liposarcoma

ESMO Open2024-03-013 citations

140TiP Brightline-4: A phase III open-label, single-arm, multicentre study to assess the safety and efficacy of brigimadlin (BI 907828), an MDM2-p53 antagonist, in patients with treatment-naïve or pretreated advanced dedifferentiated liposarcoma

ESMO Open2024-03-011 citations

Efficacy and safety of brigimadlin (BI 907828), an MDM2–p53 antagonist, in patients (pts) with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials.

Journal of Clinical Oncology2024-01-208 citations

The MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced or Metastatic Solid Tumors: Results of a Phase Ia, First-in-Human, Dose-Escalation Study

Cancer Discovery2023-06-0381 citations

A phase Ia/Ib, dose-escalation/expansion study of the MDM2–p53 antagonist BI 907828 in patients (pts) with solid tumors: Safety and efficacy in patients with dedifferentiated liposarcoma (DDLPS).

Journal of Clinical Oncology2023-06-013 citations

Longitudinal mutational analysis of <i>TP53</i> in plasma circulating tumor DNA (ctDNA) in patients (pts) with solid tumors in a phase I study of BI 907828, an MDM2–p53 antagonist.

Journal of Clinical Oncology2023-06-01

Efficacy and safety of the MDM2–p53 antagonist BI 907828 in patients with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials.

Journal of Clinical Oncology2023-01-249 citations

A phase Ia/Ib, dose-escalation/expansion study of the MDM2–p53 antagonist BI 907828 in patients with solid tumors, including advanced/metastatic liposarcoma (LPS).

Journal of Clinical Oncology2022-06-0111 citations

A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 (ezabenlimab) and BI 754111 in patients (pts) with advanced solid tumors.

Journal of Clinical Oncology2022-06-017 citations

A phase I dose-escalation study of the MDM2-p53 antagonist BI 907828 in patients (pts) with advanced solid tumors.

Journal of Clinical Oncology2021-05-2010 citations

A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 and BI 754111 in patients (pts) with advanced solid tumors.

Journal of Clinical Oncology2020-05-201 citations

Abstract 3197: BI-907828, a novel and potent MDM2-p53 antagonist, acts synergistically in a triple combination with anti-PD-1 and anti-LAG-3 antibodies in syngeneic mouse models of cancer

Cancer Research2019-07-013 citations

Abstract 3197: BI-907828, a novel and potent MDM2-p53 antagonist, acts synergistically in a triple combination with anti-PD-1 and anti-LAG-3 antibodies in syngeneic mouse models of cancer

Immunology2019-07-01

A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 (MDM2-p53 antagonist) in adult patients with advanced or metastatic solid tumors.

Journal of Clinical Oncology2019-05-203 citations