2024
990O Final results from phase I, first-in-human, dose escalation study of a first-in-class anti-ILT2 antibody, SAR444881, alone and with pembrolizumab or cetuximab, in patients with advanced solid tumors
Perets R, Stemmer S, Geva R, Golan T, Fakih M, Cohen J, Lieu C, Jin Z, Lorusso P, Friedman I, Hakim M, Ziv D, Hashmueli S, Mandel I, Moshe T, Crawford N, Abbadessa G, Perez R, Wu M, Borad M. 990O Final results from phase I, first-in-human, dose escalation study of a first-in-class anti-ILT2 antibody, SAR444881, alone and with pembrolizumab or cetuximab, in patients with advanced solid tumors. Annals Of Oncology 2024, 35: s675. DOI: 10.1016/j.annonc.2024.08.1049.Peer-Reviewed Original Research
2023
1029P Dazostinag (TAK-676) alone and in combination with pembrolizumab (pembro) in patients (pts) with advanced or metastatic solid tumors: Preliminary safety, PK/PD, and anti-tumor activity in a phase I dose escalation study supporting a recommended dose for expansion (RDE)
Olszanski A, Luke J, LoRusso P, Falchook G, Bedard P, Sanborn R, Patel S, Orr D, Gibbs J, Li C, Huang Y, Gregory R, Perera S, Xu R, Joshi A, Lee M, Raizer J, Gao X. 1029P Dazostinag (TAK-676) alone and in combination with pembrolizumab (pembro) in patients (pts) with advanced or metastatic solid tumors: Preliminary safety, PK/PD, and anti-tumor activity in a phase I dose escalation study supporting a recommended dose for expansion (RDE). Annals Of Oncology 2023, 34: s625-s626. DOI: 10.1016/j.annonc.2023.09.2168.Peer-Reviewed Original ResearchFirst-in-human phase 1 dose escalation study of the KAT6 inhibitor PF-07248144 in patients with advanced solid tumors.
Sommerhalder D, Hamilton E, Mukohara T, Yonemori K, Mita M, Yamashita T, Zheng J, Liu L, Maity A, Homji Mishra N, Bogg O, Li M, LoRusso P. First-in-human phase 1 dose escalation study of the KAT6 inhibitor PF-07248144 in patients with advanced solid tumors. Journal Of Clinical Oncology 2023, 41: 1054-1054. DOI: 10.1200/jco.2023.41.16_suppl.1054.Peer-Reviewed Original ResearchWhite blood cellsEndocrine therapyPartial responsePart 1BPhase 1 dose-escalation studyHuman phase 1 studyPreclinical anti-tumor activityDurable partial responseTreatment-related AEsAdvanced solid tumorsDose-escalation studySystemic anticancer therapyPhase 1 studyAnti-tumor activityPart 1AEscalation studyMedian agePrior linesStandard therapyDose escalationCDK4/6 inhibitorsDisease progressionBreast cancerTumor biopsiesG1-2
2020
A First-in-Human Phase I Study to Evaluate the ERK1/2 Inhibitor GDC-0994 in Patients with Advanced Solid Tumors
Varga A, Soria JC, Hollebecque A, LoRusso P, Bendell J, Huang SA, Wagle MC, Okrah K, Liu L, Murray E, Sanabria-Bohorquez SM, Tagen M, Dokainish H, Mueller L, Burris H. A First-in-Human Phase I Study to Evaluate the ERK1/2 Inhibitor GDC-0994 in Patients with Advanced Solid Tumors. Clinical Cancer Research 2020, 26: 1229-1236. PMID: 31848189, DOI: 10.1158/1078-0432.ccr-19-2574.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedDose-Response Relationship, DrugFatigueFemaleHumansMaleMAP Kinase Signaling SystemMaximum Tolerated DoseMiddle AgedMitogen-Activated Protein Kinase 1Mitogen-Activated Protein Kinase 3NauseaNeoplasmsPatient SafetyProtein Kinase InhibitorsPyridonesPyrimidinesTissue DistributionVomitingConceptsBRAF-mutant colorectal cancerColorectal cancerAdverse eventsFDG-PETCommon drug-related adverse eventsSolid tumorsDrug-related adverse eventsPhase IPartial metabolic responseAcceptable safety profileAdvanced solid tumorsDose-proportional increaseGrade 3 rashMetastatic solid tumorsSerial tumor biopsiesSingle-agent activityBest overall responseHuman phase IMAPK pathway inhibitionMultiple tumor typesStable diseaseEscalation studyPartial responseOral inhibitorPharmacodynamic effects
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
2014
Phase I and IIa studies of simtuzumab alone and in combination with FOLFIRI in patients with advanced solid tumors.
LoRusso P, Hecht J, Thai D, Hawkins M, Dong H, Tolcher A. Phase I and IIa studies of simtuzumab alone and in combination with FOLFIRI in patients with advanced solid tumors. Journal Of Clinical Oncology 2014, 32: 554-554. DOI: 10.1200/jco.2014.32.3_suppl.554.Peer-Reviewed Original ResearchTreatment-emergent AEsAdvanced solid tumorsColorectal cancerDose expansionIIa studyPhase ISolid tumorsCommon treatment-emergent AEsKRAS-mutant colorectal cancerDrug-related SAEsPhase II studyPhase IIa trialPhase IIa studyMutant colorectal cancerExtracellular matrix enzymesMedian PFSIIa trialUnacceptable toxicityEscalation studyII studyDose escalationFourth dosesTumor sizePancreatic neuroendocrinePromising efficacy
2010
381 Preliminary results of a dose escalation study of the Fibroblast Growth Factor (FGF) “trap” FP-1039 (FGFR1:Fc) in patients with advanced malignancies
Tolcher A, Papadopolous K, Patniak A, Heath E, Weise A, Prokop T, Morrone S, Zanghi J, Keer H, LoRusso P. 381 Preliminary results of a dose escalation study of the Fibroblast Growth Factor (FGF) “trap” FP-1039 (FGFR1:Fc) in patients with advanced malignancies. European Journal Of Cancer Supplements 2010, 8: 121. DOI: 10.1016/s1359-6349(10)72088-7.Peer-Reviewed Original Research
2009
Phase I study of MGCD265 administered intermittently to patients with advanced malignancies (Study 265–102)
Hong D, LoRusso P, Kurzrock R, Maroun C, Mehran M, Drouin M, Martell R, Wheler J. Phase I study of MGCD265 administered intermittently to patients with advanced malignancies (Study 265–102). Journal Of Clinical Oncology 2009, 27: e14516-e14516. DOI: 10.1200/jco.2009.27.15_suppl.e14516.Peer-Reviewed Original ResearchDose levelsSolid tumorsGrade 3 nonhematologic toxicityPhase IDrug-related AEsGrade 4 neutropeniaGrade 4 thrombocytopeniaAdvanced solid tumorsDrug-related toxicityTreatment of patientsDose-dependent increaseVariety of cancersEfficacious exposureNonhematologic toxicitySustained hypertensionAdvanced malignanciesEscalation studyFirst doseIntermittent administrationDisease progressionAvailable small moleculesPD markersXenograft modelPatientsDay 1
2007
A phase 1 dynamic accelerated titration dose escalation study of the vascular disrupting agent NPI-2358
Spear M, LoRusso P, Tolcher A, Lin C, Wang D, Heath E, Lloyd G, Cropp G, Papadopoulos K. A phase 1 dynamic accelerated titration dose escalation study of the vascular disrupting agent NPI-2358. Journal Of Clinical Oncology 2007, 25: 14097-14097. DOI: 10.1200/jco.2007.25.18_suppl.14097.Peer-Reviewed Original ResearchStable diseaseAdverse eventsDrug accumulationGrade 2 adverse eventsMultiple murine tumor modelsDose-escalation studyDose-limiting toxicityObserved adverse eventsPhase 1 studyTumor vascular endothelial cellsDirect cytotoxic activityMurine tumor modelsVascular endothelial cellsTumor vascular collapseEscalation studyFirst doseDose escalationSafety profileEfficacious dosePreclinical dataTumor regressionPancreatic adenocarcinomaAverage CmaxVascular collapsePK data
2004
A pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classification
Takimoto C, Saif M, Lorusso P, Sweeney C, Ducharme M, Chu S, Schwartz G, Danna M, De Jager R, Rowinsky E. A pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classification. Journal Of Clinical Oncology 2004, 22: 2017-2017. DOI: 10.1200/jco.2004.22.14_suppl.2017.Peer-Reviewed Original ResearchA pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classification
Takimoto C, Saif M, Lorusso P, Sweeney C, Ducharme M, Chu S, Schwartz G, Danna M, De Jager R, Rowinsky E. A pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classification. Journal Of Clinical Oncology 2004, 22: 2017-2017. DOI: 10.1200/jco.2004.22.90140.2017.Peer-Reviewed Original Research