2021
539 Phase 1 study of mRNA-2752, a lipid nanoparticle encapsulating mRNAs encoding human OX40L/IL-23/IL-36γ, for intratumoral (ITu) injection +/- durvalumab in advanced solid tumors and lymphoma
Patel M, Jimeno A, Wang D, Stemmer S, Bauer T, Sweis R, Geva R, Kummar S, Reagan P, Perets R, LoRusso P, Gupta S, Zacharek S, Laino A, Milberg O, Frederick J, Chen S, Pascarella S, Randolph W, Aanur P, Johansen L, Do K, Meehan R, Sullivan R. 539 Phase 1 study of mRNA-2752, a lipid nanoparticle encapsulating mRNAs encoding human OX40L/IL-23/IL-36γ, for intratumoral (ITu) injection +/- durvalumab in advanced solid tumors and lymphoma. 2021, a569-a569. DOI: 10.1136/jitc-2021-sitc2021.539.Peer-Reviewed Original ResearchIL-23 serum concentrationsTreatment-emergent adverse eventsPro-inflammatory cytokinesIL-23IL-36γArm BSerum concentrationsAST/ALT increasePD-L1 inhibitor durvalumabPost-treatment tumor biopsiesSquamous cell bladder cancerPK/PD modelingEmergent adverse eventsPain/swellingPD-L1 blockadeCytokine release syndromeAdvanced solid tumorsCytokine IL-22PD-L1 levelsPhase 1 studyPK/PD modelT cell infiltrationEthics BoardGood clinical practiceTreatment effects
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