2017
A phase Ib dose escalation study of combined inhibition of IDO1 (GDC-0919) and PD-L1 (atezolizumab) in patients (pts) with locally advanced or metastatic solid tumors.
Burris H, Gordon M, Hellmann M, LoRusso P, Emens L, Hodi F, Lieu C, Infante J, Tsai F, Eder J, Cleary J, Jelovac D, Tsuhako A, Mueller L, Lin R, Morrissey K, Mahrus S, Morley R, Pirzkall A, Davis S. A phase Ib dose escalation study of combined inhibition of IDO1 (GDC-0919) and PD-L1 (atezolizumab) in patients (pts) with locally advanced or metastatic solid tumors. Journal Of Clinical Oncology 2017, 35: 105-105. DOI: 10.1200/jco.2017.35.15_suppl.105.Peer-Reviewed Original ResearchMetastatic solid tumorsPD-L1Phase Ib dose-escalation studySolid tumorsEffector T cell activityPrior systemic therapyDose-escalation studyT cell activityPreliminary efficacy dataHeterogeneous patient populationDose-dependent decreaseAnti-tumor activityCombination of GDCSelect tumor typesImmunogenic stateStable diseaseTumor pharmacodynamicsBID dosingExpansion cohortSepsis syndromeTreatment discontinuationEscalation studyPartial responsePlasma kynureninePrior immunotherapy
2012
A first-in-human phase Ib study to evaluate the MEK inhibitor GDC-0973, combined with the pan-PI3K inhibitor GDC-0941, in patients with advanced solid tumors.
LoRusso P, Shapiro G, Pandya S, Kwak E, Jones C, Belvin M, Musib L, de Crespigny A, McKenzie M, Gates M, Chan I, Bendell J. A first-in-human phase Ib study to evaluate the MEK inhibitor GDC-0973, combined with the pan-PI3K inhibitor GDC-0941, in patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: 2566-2566. DOI: 10.1200/jco.2012.30.15_suppl.2566.Peer-Reviewed Original ResearchAdvanced solid tumorsPan-PI3K inhibitor GDCPhase Ib dose-escalation studySolid tumorsDays on/7 daysPartial metabolic responsePlasma PK samplesStudy drug combinationsDose-escalation studyInhibitor GDCPhase 1 trialRAS/RAF/MEKAnti-tumor activityClass I PI3K inhibitorPharmacokinetics of GDCPI3K/AktPI3K inhibitorsEvaluable ptsStable diseaseAdverse eventsPartial responseCPK elevationDose escalationElevated CPKConcurrent administration