2021
502 Recommended phase 2 dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the IL-15 superagonist SO-C101 as monotherapy in patients with advanced/metastatic solid tumors
Marabelle A, Champiat S, Galvao V, Naing A, Janku F, LoRusso P, Grell P, Sachse R, Bechard D, Kiemle-Kallee J, Garralda E. 502 Recommended phase 2 dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the IL-15 superagonist SO-C101 as monotherapy in patients with advanced/metastatic solid tumors. 2021, a534-a534. DOI: 10.1136/jitc-2021-sitc2021.502.Peer-Reviewed Original ResearchPhase 2 doseDose-limiting toxicityAdverse eventsPartial responseStable diseaseTransaminase increaseSolid tumorsDrug-related adverse eventsIL-15 receptor αCutaneous squamous cell carcinomaLocal injection site reactionsPrevious systemic therapyResults Thirty patientsSignificant partial responseTreatment-related deathsCommon adverse eventsFlu-like syndromeRelated adverse eventsInjection site reactionsMetastatic solid tumorsAdditional clinical benefitDose-escalation designSquamous cell carcinomaDose-dependent increaseT cell activation
2020
A phase I study of CD40 agonist ABBV-927 plus OX40 agonist ABBV-368 with or without the PD-1 inhibitor budigalimab in patients with advanced solid tumors.
Powderly J, Tolcher A, LoRusso P, Blaney M, Dacosta D, Henner W, McDevitt M, Miller K, Golan T. A phase I study of CD40 agonist ABBV-927 plus OX40 agonist ABBV-368 with or without the PD-1 inhibitor budigalimab in patients with advanced solid tumors. Journal Of Clinical Oncology 2020, 38: tps3147-tps3147. DOI: 10.1200/jco.2020.38.15_suppl.tps3147.Peer-Reviewed Original ResearchNon-small cell lung cancerTriple-negative breast cancerAdvanced solid tumorsDisease-specific cohortsSolid tumorsCostimulatory moleculesEastern Cooperative Oncology Group performance statusCentral nervous system metastasesPD-ligand 1 (PD-L1) inhibitorsRegulatory T cell activityNascent immune responsesPhase 2 doseNervous system metastasesProgression-free survivalPhase 1 studyT cell activityCell lung cancerDuration of responseOverall response ratePlatinum-based therapyKey costimulatory moleculesT cell activationAdaptive immune systemPrimary endpointSecondary endpoints
2017
Dose escalation results from a first-in-human, phase 1 study of the glucocorticoid-induced TNF receptor-related protein (GITR) agonist AMG 228 in patients (Pts) with advanced solid tumors.
Tran B, Carvajal R, Marabelle A, Patel S, LoRusso P, Rasmussen E, Juan G, Upreti V, Ngarmchamnanrith G, Schöffski P. Dose escalation results from a first-in-human, phase 1 study of the glucocorticoid-induced TNF receptor-related protein (GITR) agonist AMG 228 in patients (Pts) with advanced solid tumors. Journal Of Clinical Oncology 2017, 35: 2521-2521. DOI: 10.1200/jco.2017.35.15_suppl.2521.Peer-Reviewed Original ResearchGlucocorticoid-induced TNF receptor-related proteinAdvanced solid tumorsDose-limiting toxicityPhase 1 studyAdverse eventsSolid tumorsObjective responseDose escalationCell carcinomaNon-small cell lung cancerRefractory advanced colorectal cancerTreatment-emergent adverse eventsHuman IgG1 monoclonal antibodyPhase 2 doseUrothelial transitional cell carcinomaAdvanced colorectal cancerRegulatory T cellsCell lung cancerSquamous cell carcinomaTransitional cell carcinomaDose-escalation resultsT cell activationReceptor-related proteinPopulation of ptsIgG1 monoclonal antibody