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 and pharmacodynamic activity in chronic lymphocytic leukemia and small lymphocytic lymphoma in a phase 1 study
O'Brien S, Patel M, Kahl BS, Horwitz SM, Foss FM, Porcu P, Jones J, Burger J, Jain N, Allen K, Faia K, Douglas M, Stern HM, Sweeney J, Kelly P, Kelly V, Flinn I. Duvelisib, an oral dual PI3K‐δ,γ inhibitor, shows clinical and pharmacodynamic activity in chronic lymphocytic leukemia and small lymphocytic lymphoma in a phase 1 study. American Journal Of Hematology 2018, 93: 1318-1326. PMID: 30094870, PMCID: PMC8260004, DOI: 10.1002/ajh.25243.Peer-Reviewed Original ResearchConceptsChronic lymphocytic leukemiaPhase 1 studyTN patientsRR patientsLymphocytic lymphomaLymphocytic leukemiaRefractory chronic lymphocytic leukemiaMedian response durationAdvanced hematologic malignanciesPhase 3 studyOverall response rateCLL/SLLSmall lymphocytic lymphomaPatient's diarrheaExpansion cohortTransaminase elevationHematologic malignanciesPharmacodynamic activityResponse durationPatientsResponse rateΓ inhibitorDuvelisibDual inhibitorLymphoma
2012
Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma
Horwitz SM, Kim YH, Foss F, Zain JM, Myskowski PL, Lechowicz MJ, Fisher DC, Shustov AR, Bartlett NL, Delioukina ML, Koutsoukos T, Saunders ME, O'Connor OA, Duvic M. Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma. Blood 2012, 119: 4115-4122. PMID: 22394596, DOI: 10.1182/blood-2011-11-390211.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAminopterinAntimetabolites, AntineoplasticDisease ProgressionDose-Response Relationship, DrugDrug Administration ScheduleDrug EruptionsFatigueFemaleGastrointestinal DiseasesHumansLymphoma, T-Cell, CutaneousMaleMiddle AgedMucositisNeutropeniaSalvage TherapySkin NeoplasmsThrombocytopeniaConceptsCutaneous T-cell lymphomaRefractory cutaneous T-cell lymphomaT-cell lymphomaAdverse eventsSystemic therapyPrimary cutaneous anaplastic large cell lymphomaCommon grade 3 adverse eventsOnly grade 4 adverse eventCutaneous anaplastic large cell lymphomaGrade 3 adverse eventsGrade 4 adverse eventsAnaplastic large cell lymphomaPrior systemic therapyAcceptable toxicity profileLong-term dosingLarge cell lymphomaFolate carrier 1De-escalation strategiesAcceptable toxicityExpansion cohortStarting doseSézary syndromeSystemic treatmentDosing regimenMycosis fungoides