2019
Phase 1a/1b study of first-in-class B7-H4 antibody, FPA150, as monotherapy in patients with advanced solid tumors.
Sachdev J, Bauer T, Chawla S, Pant S, Patnaik A, Wainberg Z, Inamdar S, Marina N, Sun S, Schmidt M, Xiang H, LoRusso P. Phase 1a/1b study of first-in-class B7-H4 antibody, FPA150, as monotherapy in patients with advanced solid tumors. Journal Of Clinical Oncology 2019, 37: 2529-2529. DOI: 10.1200/jco.2019.37.15_suppl.2529.Peer-Reviewed Original ResearchTreatment-related AEsAdvanced solid tumorsB7-H4Solid tumorsExploration cohortEndometrial cancerDose escalationTreatment-related serious adverse eventsAntibody-dependent cell-mediated cytotoxicityB7-H4 antibodyDose-proportional exposureSerious adverse eventsT cell activityCell-mediated cytotoxicityFavorable safety profileT cell functionAnti-tumor activityPreliminary biomarkerPrior therapyTreatment biopsiesAdverse eventsMost patientsSafety profileB7 familyEfficacy data
2012
Targeting hyaluronan (HA) in tumor stroma: A phase I study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of pegylated hyaluronidase (PEGPH20) in patients with solid tumors.
Borad M, Ramanathan R, Bessudo A, LoRusso P, Shepard H, Maneval D, Jiang P, Zhu J, Frost G, Infante J. Targeting hyaluronan (HA) in tumor stroma: A phase I study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of pegylated hyaluronidase (PEGPH20) in patients with solid tumors. Journal Of Clinical Oncology 2012, 30: 2579-2579. DOI: 10.1200/jco.2012.30.15_suppl.2579.Peer-Reviewed Original ResearchMusculoskeletal eventsSolid tumorsFDG-PETDCE-MRITumor biopsiesTumor perfusionInterstitial fluid pressureOngoing phase 1 studiesTreatment-refractory solid tumorsWeekly dosing scheduleDose limiting toxicitiesPhase 1 studyWeeks of dosingEfficacy of chemotherapyTerminal half lifeFDG-PET imagesOral dexamethasoneTumor hyaluronanCytotoxic chemotherapyMost patientsDosing schedulesLimiting toxicitiesPoor prognosisSystemic exposureHA depletion