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Therapy Name | BI 907828 + Ezabenlimab |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
BI 907828 | BI907828|BI-907828|Brigimadlin | MDM2 Inhibitor 23 | BI 907828 is an MDM2 inhibitor that potentially inhibits tumor growth and improves anti-tumor immunity (PMID: 31201607; Cancer Res 2018;78(13 Suppl):Abstract nr 4866). | |
Ezabenlimab | BI754091|BI-754091|BI 754091 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 | Ezabenlimab (BI 754091) is a monoclonal antibody that targets PD-1 (PDCD1) and inhibits binding of the PD-L1 (CD274) ligand, potentially resulting in enhanced anti-tumor immune response (J Clin Oncol. 36, no. 5_suppl (February 2018) 212-212). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
TP53 wild-type | Advanced Solid Tumor | predicted - sensitive | BI 907828 + Ezabenlimab | Phase I | Actionable | In a Phase I trial, Ezabenlimab (BI 754091) and BI 907828 combination therapy demonstrated safety in patients with TP53 wild-type advanced solid tumors (n=9), and resulted in a partial response (PR) in 2 patients with biliary tract carcinoma, 1 urothelial carcinoma patient, and 1 myxoid liposarcoma patient, an unconfirmed PR in an intrahepatic cholangiocarcinoma patient, and stable disease in 4 patients with liposarcoma or gastric cancer (J Clin Oncol 40, no. 16_suppl (June 01, 2022) 3095; NCT03964233). | detail... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT03964233 | Phase I | BI 907828 + Ezabenlimab + Miptenalimab BI 907828 + Ezabenlimab | 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) | Active, not recruiting | USA | NLD | HUN | GBR | FRA | ESP | DEU | BEL | AUS | 2 |
NCT06084689 | Phase II | BI 907828 + Ezabenlimab | Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures (EMPIRE) | Not yet recruiting | FRA | 0 |