2021
SGNTGT-001: A phase 1 study of SEA-TGT, an effector-function enhanced monoclonal antibody (mAb), in advanced malignancies (trial in progress).
Garralda E, Sanborn R, Minchom A, Davar D, Curigliano G, Ribrag V, Mehta A, Foss F, Zain J, Forero-Torres A, Ansell S. SGNTGT-001: A phase 1 study of SEA-TGT, an effector-function enhanced monoclonal antibody (mAb), in advanced malignancies (trial in progress). Journal Of Clinical Oncology 2021, 39: tps2657-tps2657. DOI: 10.1200/jco.2021.39.15_suppl.tps2657.Peer-Reviewed Original ResearchAnti-tumor immune responseInhibitory immune checkpoint receptorsRegulatory cell depletionObjective response ratePhase II doseProgression-free survivalDose-limiting toxicityMetastatic solid tumorsPhase 1 studyT cell responsesT cell immunoreceptorImmune checkpoint receptorsImmune cell activationPK-PD correlationsAnti-tumor activityExpansion cohortPrimary endpointSecondary endpointsAdvanced malignanciesAdverse eventsLaboratory abnormalitiesMemory CD8Overall survivalComplete responseNK cells
2018
Duvelisib, an oral dual PI3K‐δ, γ inhibitor, shows clinical activity in indolent non‐Hodgkin lymphoma in a phase 1 study
Flinn IW, Patel M, Oki Y, Horwitz S, Foss FF, Allen K, Douglas M, Stern H, Sweeney J, Kharidia J, Kelly P, Kelly VM, Kahl B. Duvelisib, an oral dual PI3K‐δ, γ inhibitor, shows clinical activity in indolent non‐Hodgkin lymphoma in a phase 1 study. American Journal Of Hematology 2018, 93: 1311-1317. PMID: 30033575, PMCID: PMC6220789, DOI: 10.1002/ajh.25228.Peer-Reviewed Original ResearchConceptsIndolent non-Hodgkin lymphomaDose-limiting toxicityNon-Hodgkin lymphomaClinical activityINHL patientsHematologic malignanciesClinical developmentGrade 3 transaminase elevationMedian progression-free survivalOral dual inhibitorAcute respiratory failureE. coli sepsisElevated liver enzymesOpen-label studyAcceptable safety profileAdvanced hematologic malignanciesDose-escalation phaseGrade 3 rashProgression-free survivalSevere adverse eventsPhase 1 studyDuration of responseFavorable clinical activityFurther clinical developmentBID cohort