2022
A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance.
Yap T, LoRusso P, Wong D, Hu-Lieskovan S, Papadopoulos K, Holz J, Grabowska U, Gradinaru C, Leung K, Marshall S, Reader C, Russell R, Sainson R, Seal C, Shepherd C, Germaschewski F, Gliddon D, Stern O, Young L, Brewis N, Kayitalire L, Morrow M. A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance. Clinical Cancer Research 2022, 29: 888-898. PMID: 36342102, DOI: 10.1158/1078-0432.ccr-22-1449.Peer-Reviewed Original ResearchConceptsDisease control rateLAG-3PD-L1Advanced cancerOverall disease control rateDisease controlPeripheral effector cellsPhase 2 doseSerious adverse eventsPhase 1 studySoluble LAG-3Tetravalent bispecific antibodyPrior regimensStable diseaseDose expansionMetastatic settingAdverse eventsPartial responseEffector cellsClinical benefitControl rateSustained elevationTitration designPharmacodynamic activityHuman studies
2012
A first-in-human, phase I safety and pharmacokinetic study of genz-644282, a non-camptothecin topoisomerase I inhibitor, in patients with advanced solid tumors.
Han H, Tan A, Weiss G, Sullivan D, Strosberg J, Collins S, Moss R, Wu J, Ewesuedo R, LoRusso P. A first-in-human, phase I safety and pharmacokinetic study of genz-644282, a non-camptothecin topoisomerase I inhibitor, in patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: 2534-2534. DOI: 10.1200/jco.2012.30.15_suppl.2534.Peer-Reviewed Original ResearchTopoisomerase I inhibitorDay scheduleCell lungTreatment-emergent adverse eventsNon-small cell lungEmergent adverse eventsPhase I safetyAdvanced solid tumorsAccelerated titration designPK-PD relationshipSmall cell lungDistinct clinical profileDose-exposure relationshipPharmacokinetic-pharmacodynamic modelI inhibitorNon-camptothecin topoisomerase I inhibitorsStable diseaseI safetyAdverse eventsPhase I developmentWeekly dosesClinical profileEfficacy dataTitration designSafety data