^
6ms
Platform Trial Evaluating Safety and Efficacy of BI 754091 Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours (clinicaltrials.gov)
P2, N=212, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Jun 2024 --> May 2025 | Trial primary completion date: Jun 2024 --> May 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
ezabenlimab (BI 754091) • BI 836880 • miptenalimab (BI 754111)
6ms
Enrollment closed • Combination therapy • Metastases
|
TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
|
TP53 mutation • TP53 wild-type • TP53 amplification
|
brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
8ms
Phase classification • Combination therapy • Metastases
|
TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
|
TP53 mutation • TP53 wild-type • TP53 amplification
|
brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
over1year
Trial completion • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • ALK rearrangement
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
over1year
Trial completion • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
|
PD-L1 expression • TMB-H • MSI-H/dMMR • PD-L1 overexpression • EGFR wild-type • ALK wild-type
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
over1year
Zr-immuno-PET using the anti-LAG-3 tracer [Zr]Zr-BI 754111: demonstrating target specific binding in NSCLC and HNSCC. (PubMed, Eur J Nucl Med Mol Imaging)
[Zr]Zr-BI-754111 PET imaging shows favorable technical and biological characteristics for developing a potential predictive imaging biomarker for LAG-3-directed therapies.
Journal • PD(L)-1 Biomarker • IO biomarker
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
2years
Trial primary completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • ALK rearrangement
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
2years
PHASE IA/IB, DOSE-ESCALATION/EXPANSION STUDY OF THE MURINE DOUBLE MINUTE 2–TUMOR PROTEIN 53 ANTAGONIST BI 907828 IN COMBINATION WITH IMMUNE CHECKPOINT INHIBITORS IN PATIENTS WITH ADVANCED SOLID TUMORS (CTOS 2022)
This Phase Ia/Ib study (NCT03964233) is assessing BI 907828, an MDM2–p53 antagonist, combined with immune checkpoint inhibitors in TP53 wild-type cancers. In Phase Ia (dose escalation), patients with advanced/metastatic solid tumors received escalating doses of BI 907828 guided by a Bayesian Logistic Regression Model (starting dose 10 mg orally) plus ezabenlimab 240 mg (anti-PD-1 antibody) and BI 754111 600 mg (anti-LAG-3 antibody) every 21 days (q3w). The doublet combination of BI 907828 plus ezabenlimab showed a manageable safety profile and early signs of anti-tumor activity. Eleven patients remain on treatment; recruitment is ongoing.
P1 data • Preclinical • Combination therapy • Checkpoint inhibition
|
MDM2 (E3 ubiquitin protein ligase)
|
TP53 wild-type
|
brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
2years
Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
|
PD-L1 expression • TMB-H • MSI-H/dMMR • PD-L1 overexpression • EGFR wild-type • ALK wild-type
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
2years
Trial completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • ALK rearrangement
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
over2years
Trial completion date • Trial primary completion date • Combination therapy
|
TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
|
TP53 mutation • TP53 wild-type • TP53 amplification
|
brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
almost3years
Trial completion date • Trial primary completion date • Combination therapy
|
BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
|
TP53 mutation • BRAF V600E • EGFR mutation • BRAF V600 • EGFR T790M • TP53 wild-type • ALK rearrangement
|
brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
3years
Clinical • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • ALK rearrangement
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
3years
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
|
PD-L1 expression • TMB-H • MSI-H/dMMR • PD-L1 overexpression • EGFR wild-type • ALK wild-type
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
3years
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • ALK rearrangement
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
3years
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
|
PD-L1 expression • TMB-H • MSI-H/dMMR • PD-L1 overexpression
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
over3years
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • ALK rearrangement
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
almost4years
Clinical • Enrollment open • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • ALK rearrangement
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
4years
Clinical • Enrollment closed • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • ALK rearrangement
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
4years
Clinical • Enrollment closed • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
|
PD-L1 expression • TMB-H • MSI-H/dMMR • PD-L1 overexpression
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
4years
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
|
PD-L1 expression • TMB-H • MSI-H/dMMR • PD-L1 overexpression
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
over4years
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
|
TP53 mutation • BRAF V600E • EGFR mutation • BRAF V600 • EGFR T790M • ALK rearrangement
|
brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
over4years
Clinical • Enrollment open • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • ALK rearrangement
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
over4years
Clinical • Enrollment open • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
|
PD-L1 expression • TMB-H • MSI-H/dMMR • PD-L1 overexpression
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
over4years
[VIRTUAL] A phase I study of BI 754111, an anti-LAG-3 monoclonal antibody (mAb), in combination with BI 754091, an anti-PD-1 mAb: Biomarker analyses from the microsatellite stable metastatic colorectal cancer (MSS mCRC) cohort (AACR-II 2020)
BI 754111 plus BI 754091 showed encouraging results in this IO-refractory MSS mCRC population. Biomarker analyses showed activation of the immune system in peripheral blood and the tumor, consistent with other CPIs.
P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
|
PD-L1 expression • LAG3 expression
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
over4years
Clinical • Enrollment open • Combination therapy
|
BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
|
TP53 mutation • BRAF V600E • EGFR mutation • BRAF V600 • EGFR T790M • ALK rearrangement
|
brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
over4years
[VIRTUAL] 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. (ASCO 2020)
Phase Ib will include at least 140 evaluable pts (80 pts in cohort 1 and 20 pts each in cohorts 2–4). Research Funding: Boehringer Ingelheim
Clinical • P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
TP53 (Tumor protein P53)
|
TP53 mutation
|
brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
over4years
Clinical • Trial suspension • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
|
PD-L1 expression • TMB-H • MSI-H/dMMR • PD-L1 overexpression
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)
almost5years
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
|
PD-L1 expression • TMB-H • MSI-H/dMMR • PD-L1 overexpression
|
ezabenlimab (BI 754091) • miptenalimab (BI 754111)