2023
First-in-human first-in-class phase 1/2a study of the next generation CDK4-selective inhibitor PF-07220060 in patients (pts) with advanced solid tumors, enriched for HR+ HER2- mBC who progressed on prior CDK4/6 inhibitors and endocrine therapy.
Yap T, Giordano A, Hamilton E, LoRusso P, Bowers M, Basu C, Billotte S, Delioukina M, Liu F, Yang J, Sharma M. First-in-human first-in-class phase 1/2a study of the next generation CDK4-selective inhibitor PF-07220060 in patients (pts) with advanced solid tumors, enriched for HR+ HER2- mBC who progressed on prior CDK4/6 inhibitors and endocrine therapy. Journal Of Clinical Oncology 2023, 41: 3009-3009. DOI: 10.1200/jco.2023.41.16_suppl.3009.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsHR+/HER2- MBCEndocrine therapySolid tumorsCDK4/6 inhibitorsMedian progression-free survivalClinical benefit responseMedian prior linesDose-limiting toxicityProgression-free survivalAdvanced/metastatic breast cancerPhase 1/2a studyLines of treatmentFirst-in-humanDose-dependent increaseAnti-tumor activityDose expansionHER2-MBCSecondary/exploratory objectivesDose escalationData cutoffECOG PSSystemic therapyMedian ageMulticenter trialA phase 1a dose-escalation study of PY159, a monoclonal antibody targeting TREM1 (triggering receptor expressed on myeloid cells 1).
Winer I, Patnaik A, Barve M, Kummar S, Schenk E, LoRusso P, Yeku O, Fu S, Jahchan N, Myers M, Liang L, Deegan D, Jackson L, Li Y, Reyno L, Chamberlain M. A phase 1a dose-escalation study of PY159, a monoclonal antibody targeting TREM1 (triggering receptor expressed on myeloid cells 1). Journal Of Clinical Oncology 2023, 41: 2523-2523. DOI: 10.1200/jco.2023.41.16_suppl.2523.Peer-Reviewed Original ResearchSingle agentDose levelsNon-small cell lung cancerAdvanced refractory solid tumorsDose-escalation study designImmune-related adverse eventsTriple-negative breast cancerImmune checkpoint inhibitorsAcceptable safety profileDose-escalation studyRefractory solid tumorsCell lung cancerArchival tumor tissueEnrollment of subjectsImmune-related reactionsDose proportionalECOG PSRECIST 1.1Stable diseaseTREM1 expressionCheckpoint inhibitorsAdverse eventsPartial responseRadiographic responseGynecologic cancer
2009
Sunitinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors: Updated phase I study results
Heath E, Blumenschein G, Cohen R, LoRusso P, LoConte N, Kim S, Chao R, Wilding G. Sunitinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors: Updated phase I study results. Journal Of Clinical Oncology 2009, 27: e14509-e14509. DOI: 10.1200/jco.2009.27.15_suppl.e14509.Peer-Reviewed Original ResearchAdvanced solid tumorsAdverse eventsSolid tumorsDose-escalation cohortsUseful treatment optionTyrosine kinase inhibitorsDetermination of MTDContinuation protocolIntolerant GISTMore DLTsSchedule 2/1Unconfirmed PRECOG PSMeasurable diseaseOverall tolerabilityEscalation cohortsMedian ageOral sunitinibPartial responseAdditional patientsAdvanced RCCDose escalationClinical benefitPT cohortTreatment options
2007
A phase I, first in man study of weekly IMC-A12, a fully human insulin like growth factor-I receptor IgG1 monoclonal antibody, in patients with advanced solid tumors
Higano C, Yu E, Whiting S, Gordon M, LoRusso P, Fox F, Katz T, Roecker J, Schwartz J. A phase I, first in man study of weekly IMC-A12, a fully human insulin like growth factor-I receptor IgG1 monoclonal antibody, in patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 3505-3505. DOI: 10.1200/jco.2007.25.18_suppl.3505.Peer-Reviewed Original ResearchIMC-A12IgG1 monoclonal antibodySolid tumorsAdvanced refractory solid tumorsHuman anti-human antibodiesMedian age 56 yearsMonoclonal antibodiesNon-compartmental PK analysisGrade 2 anemiaGrade 3 hyperglycemiaHuman IgG1 monoclonal antibodyStable radiographic diseaseTreatment related toxicityInfusion-related reactionsAdvanced solid tumorsAge 56 yearsRefractory solid tumorsHuman insulinPhase I trialWeek observation periodAnti-human antibodiesDiscolored fecesECOG PSStable diseaseStudy discontinuation