2024
A phase 1 dose expansion study of a first-in-class KAT6 inhibitor (PF-07248144) in patients with advanced or metastatic ER+ HER2− breast cancer.
Mukohara T, Park Y, Sommerhalder D, Yonemori K, Kim S, Kim J, Iwata H, Yamashita T, Layman R, Kim G, Im S, Lindeman G, Rugo H, Liyanage M, Homji Mishra N, Maity A, Bogg O, Liu L, Li M, LoRusso P. A phase 1 dose expansion study of a first-in-class KAT6 inhibitor (PF-07248144) in patients with advanced or metastatic ER+ HER2− breast cancer. Journal Of Clinical Oncology 2024, 42: 3006-3006. DOI: 10.1200/jco.2024.42.16_suppl.3006.Peer-Reviewed Original ResearchHER2- metastatic breast cancerTreatment-related adverse eventsMetastatic breast cancerCirculating tumor DNABreast cancerGene mutationsFrequent treatment-related adverse eventsMedian duration of follow-upAntitumor activityDuration of follow-upClinical benefit rateProgression-free survivalHER2 breast cancerMutant allele frequencyExpansion doseFulvestrant combinationMedian DoRESR1 mutationsMetastatic settingDose modificationEndocrine therapySystemic therapyMedian durationTumor DNACDK4/6 inhibitors
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 trial
2017
Phase 1 safety of ICOS agonist antibody JTX-2011 alone and with nivolumab (nivo) in advanced solid tumors; predicted vs observed pharmacokinetics (PK) in ICONIC.
Burris H, Callahan M, Tolcher A, Kummar S, Falchook G, Pachynski R, Tykodi S, Gibney G, Seiwert T, Gainor J, LoRusso P, Hilbert J, Apgar J, Hua F, Burke J, Lazaro M, Clancy M, Ding B, Trehu E, Yap T. Phase 1 safety of ICOS agonist antibody JTX-2011 alone and with nivolumab (nivo) in advanced solid tumors; predicted vs observed pharmacokinetics (PK) in ICONIC. Journal Of Clinical Oncology 2017, 35: 3033-3033. DOI: 10.1200/jco.2017.35.15_suppl.3033.Peer-Reviewed Original ResearchAdverse eventsTarget engagementPK dataCD4 T effector cellsGrade 3 adverse eventsGrade 1Inducible Co-StimulatorPhase 1 SafetyPrior systemic therapyAdvanced solid tumorsDose limiting toxicitiesT effector cellsPhase 1 studyHours post infusionAgonist monoclonal antibodyNon-tumor tissuesTriple-negative breastQuantitative systems pharmacology modelExposure increasesPreclinical potencyQ21 daysNeck painInfusion reactionsRegulatory cellsSystemic therapy
2015
Phase I study of ABT-700, an anti-c-Met antibody, in patients (pts) with advanced gastric or esophageal cancer (GEC).
Kang Y, LoRusso P, Salgia R, Yen C, Lin C, Ramanathan R, Kaminker P, Sokolova I, Bhathena A, Wang L, Naumovski L, Strickler J. Phase I study of ABT-700, an anti-c-Met antibody, in patients (pts) with advanced gastric or esophageal cancer (GEC). Journal Of Clinical Oncology 2015, 33: 167-167. DOI: 10.1200/jco.2015.33.3_suppl.167.Peer-Reviewed Original ResearchAnti-c-Met antibodySingle-agent activityMET amplificationProgressive diseasePartial responseSubstantial single-agent activityGood responsePrimary untreated tumorsRECIST version 1.1Treatment-refractory tumorsDose-escalation phaseHuman xenograft tumorsC-Met overexpressionPrimary tumor tissuesTumor biopsy tissueLonger PFSAdvanced gastricAdverse eventsPrior linesSystemic therapyRecurrent tumorsPatient populationEsophageal cancerPrimary tumorEscalation phase
2012
Results from a phase Ib study of trastuzumab emtansine (T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab.
Modi S, Elias A, LoRusso P, Samant M, Guardino E, Althaus B, Krop I. Results from a phase Ib study of trastuzumab emtansine (T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab. Journal Of Clinical Oncology 2012, 30: 528-528. DOI: 10.1200/jco.2012.30.15_suppl.528.Peer-Reviewed Original ResearchHER2-positive metastatic breast cancerMetastatic breast cancerT-DM1Prior systemic therapyPhase Ib studyPhase II studyDose-escalation studySingle-agent activityDuration of responseDose escalation schemeFuture clinical trialsDLT criteriaII studyMedian ageSystemic therapyExtension trialPreclinical dataTrastuzumab emtansineClinical trialsMedian numberToxicity CriteriaBreast cancerIb studyPhase IbQ3w