The MDM2–p53 antagonist BI 907828 in patients with advanced or metastatic solid tumors: results of a phase Ia, first-in-human, dose-escalation study
LoRusso P, Yamamoto N, Patel M, Laurie S, Bauer T, Geng J, Davenport T, Teufel M, Li J, Lahmar M, Gounder M. The MDM2–p53 antagonist BI 907828 in patients with advanced or metastatic solid tumors: results of a phase Ia, first-in-human, dose-escalation study. Cancer Discovery 2023, 13: 1802-1813. PMID: 37269344, PMCID: PMC10401071, DOI: 10.1158/2159-8290.cd-23-0153.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsSolid tumorsDay 1Common treatment-related adverse eventsGrowth differentiation factor-15 levelsMDM2-p53 antagonistsManageable safety profileAdvanced solid tumorsDose-escalation studyDose-limiting toxicityMetastatic solid tumorsDose-dependent increaseIA/IBAdverse eventsSafety profilePreliminary efficacyDedifferentiated liposarcomaClinical investigationCommon gradePatientsRelated commentaryIssue featureTarget engagementAntitumor activityTumorsEfficacy 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.
Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Gounder M, Geng J, Li J, Teufel M, Maerten A, LoRusso P. 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 Oncology 2023, 41: 543-543. DOI: 10.1200/jco.2023.41.4_suppl.543.Peer-Reviewed Original ResearchAdvanced biliary tract cancerBiliary tract cancerTreatment-related AEsMost common gradeMonotherapy trialsCombination trialsStable diseaseTract cancerExpansion trialGallbladder carcinomaCommon gradeAnti-PD-1 antibodyWhite blood cell countManageable safety profileAdvanced solid tumorsBiliary tract adenocarcinomaBlood cell countRange of malignanciesPreclinical antitumor activityNegative prognostic markerPotential antitumor strategyAmpullary adenocarcinomaIIb trialAmpullary carcinomaSafety profile