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Brigimadlin

DRUG6 trials

Sponsors

Kanako Taguchi, Boehringer Ingelheim

Conditions

Advanced Soft Tissue SarcomaBiliary Tract CancerBladder CancerLiposarcoma, DedifferentiatedLung NeoplasmsMyxofibrosarcoma (MFS)Pancreatic NeoplasmsSolid Tumors

Phase 2

Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma
CompletedNCT05218499
Boehringer IngelheimLiposarcoma, Dedifferentiated
Start: 2022-03-31End: 2026-01-26Updated: 2026-03-02
Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder
CompletedNCT05512377
Boehringer IngelheimBiliary Tract Cancer, Bladder Cancer, Lung Neoplasms +2
Start: 2022-12-13End: 2025-09-25Updated: 2026-07-21
A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine
Active, not recruitingNCT06619509
Boehringer IngelheimSolid Tumours
Start: 2024-12-30End: 2030-12-30Updated: 2026-09-01
A study to test long-term treatment with brigimadlin in people with solid tumours who took part in a previous study with this medicine
RecruitingJPRN-jRCT2031240625
Kanako Taguchisolid tumours
Start: 2025-01-21Target: 50Updated: 2026-05-25

Phase 3

Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated Liposarcoma
CompletedNCT06058793
Boehringer IngelheimLiposarcoma, Dedifferentiated
Start: 2023-12-13End: 2025-12-12Updated: 2026-01-09
Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Tissue Sarcoma
WithdrawnNCT06370871
Boehringer IngelheimAdvanced Soft Tissue Sarcoma, Myxofibrosarcoma (MFS), Undifferentiated Pleomorphic Sarcoma (UPS)
Start: 2024-06-27End: 2028-10-13Updated: 2024-07-17

Related Papers

Brigimadlin Versus Doxorubicin in Advanced Dedifferentiated Liposarcoma: Efficacy, Safety and Translational Data from Brightline-1, a Randomized Phase 2/3 Trial.
2026-06-10
Discovery and Characterization of Brigimadlin, a Novel and Highly Potent MDM2–p53 Antagonist Suitable for Intermittent Dose Schedules
Molecular Cancer Therapeutics2024-09-119 citations
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
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
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 IIa/IIb, open-label trial of BI 907828, an MDM2–p53 antagonist, in patients with locally advanced/metastatic biliary tract carcinoma or pancreatic ductal adenocarcinoma: Brightline-2.
Journal of Clinical Oncology2023-06-018 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
Brightline-1: phase II/III trial of the MDM2–p53 antagonist BI 907828 versus doxorubicin in patients with advanced DDLPS
Future Oncology2023-03-0137 citations
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 II/III, randomized, open-label, multicenter study of BI 907828 compared to doxorubicin in the first-line treatment of patients with advanced dedifferentiated liposarcoma (DDLPS): Brightline-1.
Journal of Clinical Oncology2022-06-01