2024
Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103)
Garralda E, Oh Y, Italiano A, Bedard P, Delord J, Calvo E, LoRusso P, Wainberg Z, Cervantes A, Rodriguez‐Vida A, Shemesh C, Sane R, Mendus D, Ding H, Hendricks R, Meng R, Cho B, Kim T, Wu B. Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103). The Journal Of Clinical Pharmacology 2024, 64: 544-554. PMID: 38105505, DOI: 10.1002/jcph.2397.Peer-Reviewed Original ResearchSolid tumorsMixed solid tumorsDose-proportional mannerDrug-drug interactionsSlower elimination phaseSequential dosingInter-individual variabilityIntravenous infusionSystemic exposureImmunogenicity assessmentAtezolizumabHuman studiesElimination phasePK dataPK profilesPK propertiesPatientsMonoclonal antibodiesSerum samplesPharmacokineticsDays/Multiple timepointsSingle timepointGeometric meanQ4W
2022
Phase 1 trial of TIM-3 inhibitor cobolimab monotherapy and in combination with PD-1 inhibitors nivolumab or dostarlimab (AMBER).
Falchook G, Ribas A, Davar D, Eroglu Z, Wang J, Luke J, Hamilton E, Di Pace B, Wang T, Ghosh S, Dhar A, Borgovan T, Waszak A, LoRusso P. Phase 1 trial of TIM-3 inhibitor cobolimab monotherapy and in combination with PD-1 inhibitors nivolumab or dostarlimab (AMBER). Journal Of Clinical Oncology 2022, 40: 2504-2504. DOI: 10.1200/jco.2022.40.16_suppl.2504.Peer-Reviewed Original ResearchTreatment-related treatment-emergent adverse eventsNon-small cell lung cancerPD-1 inhibitor nivolumabTreatment-emergent adverse eventsTumor-infiltrating T cellsPreliminary anti-tumor activityPhase 2 doseOpen-label studyPD-1 inhibitorsAdvanced solid tumorsPhase 2 studyDose-proportional mannerPhase 1 trialT cell suppressionCell lung cancerTherapeutic dose rangeMost common cancersAnti-tumor activityDose delaysPrior therapyInhibitor nivolumabPrimary endpointTim-3Adverse eventsPeritoneal mesothelioma
2013
Phase I, dose-escalation study of the investigational drug TAK-733, an oral MEK inhibitor, in patients (pts) with advanced solid tumors.
Adjei A, LoRusso P, Ribas A, Sosman J, Pavlick A, Dy G, Zhou X, Gangolli E, Walker R, Kneissl M, Faucette S, Neuwirth R, Bozon V. Phase I, dose-escalation study of the investigational drug TAK-733, an oral MEK inhibitor, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2528-2528. DOI: 10.1200/jco.2013.31.15_suppl.2528.Peer-Reviewed Original ResearchAdvanced solid tumorsDrug-related AEsSolid tumorsAcneiform dermatitisTAK-733Creatine phosphokinase increaseECOG PS 0Oral MEK inhibitorDose-escalation studyDose-proportional mannerMean accumulation ratioPeripheral blood samplesAnti-tumor activitySteady-state exposurePower model analysisStable diseasePS 0Partial responseEvaluable tumorsPeripheral bloodPustular rashBlood samplesXenograft modelHuman studiesMaximal efficacy