2023
A 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
2020
Phase I Dose-Escalation and -Expansion Study of Telisotuzumab (ABT-700), an Anti–c-Met Antibody, in Patients with Advanced Solid Tumors
Strickler JH, LoRusso P, Salgia R, Kang YK, Yen C, Lin CC, Ansell P, Motwani M, Wong S, Yue H, Wang L, Reilly E, Afar D, Naumovski L, Ramanathan RK. Phase I Dose-Escalation and -Expansion Study of Telisotuzumab (ABT-700), an Anti–c-Met Antibody, in Patients with Advanced Solid Tumors. Molecular Cancer Therapeutics 2020, 19: 1210-1217. PMID: 32127466, DOI: 10.1158/1535-7163.mct-19-0529.Peer-Reviewed Original ResearchConceptsAdvanced solid tumorsSolid tumorsStable diseaseDose escalationCommon treatment-related adverse eventsAnti-c-Met antibodyTreatment-related adverse eventsDose-expansion phaseI Dose-EscalationAcceptable safety profileResponse Evaluation CriteriaDose-limiting toxicitySubset of patientsLinear pharmacokinetic profilePeak plasma concentrationAcute infusion reactionsHuman phase IDose cohortsDose expansionRECIST criteriaAdverse eventsEscalation cohortsInfusion reactionsObjective responsePartial responseA 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
2019
343P Phase I dose escalation study of a selective androgen receptor modulator RAD140 in estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer (BC)
Hamilton E, Vidula N, Ma C, LoRusso P, Bagley R, Yu Z, Annett M, Weitzman A, Conlan M, Weise A. 343P Phase I dose escalation study of a selective androgen receptor modulator RAD140 in estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer (BC). Annals Of Oncology 2019, 30: v123. DOI: 10.1093/annonc/mdz242.038.Peer-Reviewed Original ResearchProstate-specific antigenSelective AR modulatorsALT/ASTBreast cancerMetastatic BCRadius HealthAndrogen receptorHER2-negative breast cancerSerum prostate-specific antigenAR agonist activityGenentech/RocheWeight/appetiteAntitumor activityFrequent adverse eventsAcceptable safety profileKey eligibility criteriaMetastatic breast cancerPhase 1 studyHormone-binding globulinAndrogen-responsive tissuesDrug-related deathsNegative breast cancerBristol-Myers SquibbFlatiron HealthStable disease457P First-in-human study of ABBV-621 in patients (pts) with previously treated sold tumours: Dose-optimization cohorts
Calvo E, de Jonge M, Rasco D, Moreno V, Chang Y, Chiney M, Motwani M, Penugonda S, Petrich A, Ratain M, LoRusso P. 457P First-in-human study of ABBV-621 in patients (pts) with previously treated sold tumours: Dose-optimization cohorts. Annals Of Oncology 2019, 30: v169-v170. DOI: 10.1093/annonc/mdz244.019.Peer-Reviewed Original ResearchDose levelsPancreatic cancerNon-cardiac chest painGenentech/RochePhase 2 dosePrior treatment regimensAntitumor activityAcceptable safety profileDose-limiting toxicityRoche/GenentechDeath receptor 4Bristol-Myers SquibbEligible ptsPleuritic painStable diseaseChest painGrade 3/4Respiratory failureMedian durationPartial responseToxic hepatitisDose escalationTreatment regimensSafety profileConclusion Administration
2013
Phase I study of REGN421 (R)/SAR153192, a fully-human delta-like ligand 4 (Dll4) monoclonal antibody (mAb), in patients with advanced solid tumors.
Jimeno A, LoRusso P, Strother R, Diamond J, Plato L, Younger A, Messersmith W, Kittaneh M, Sawyer D, Adriaens L, Liu L, Kao R, DiCioccio A, Brownstein C, Lowy I, Trail P, Chiorean E. Phase I study of REGN421 (R)/SAR153192, a fully-human delta-like ligand 4 (Dll4) monoclonal antibody (mAb), in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2502-2502. DOI: 10.1200/jco.2013.31.15_suppl.2502.Peer-Reviewed Original ResearchAbdominal painVentricular dysfunctionSolid tumorsGrade 3 nauseaGrade 3/4 AEsPhase II doseRight ventricular dysfunctionAcceptable safety profileAdvanced solid tumorsDose-escalation trialAnti-tumor activityBNP increaseCA125 responseHuman Dll4Prolonged SDsEscalation trialExpansion cohortPulmonary hypertensionLaboratory abnormalitiesDose escalationAdvanced cancerSafety profileFrequent treatmentHypertensionNausea
2012
1111PD Expanded Access Study of Advanced Bcc Patients Treated with the Hedgehog-Pathway Inhibitor Vismodegib
Weiss G, Oro A, Chang A, Solomon J, LoRusso P, Hamid O, Chen D, McKenna E, Feng S, Hainsworth J. 1111PD Expanded Access Study of Advanced Bcc Patients Treated with the Hedgehog-Pathway Inhibitor Vismodegib. Annals Of Oncology 2012, 23: ix362. DOI: 10.1016/s0923-7534(20)33683-8.Peer-Reviewed Original ResearchAdverse eventsClinical activitySafety profileDisease progressionSpeakers bureauAdvanced basal cell carcinomaInvestigator-assessed response ratePivotal phase II studiesSeverity of AEsTreatment-emergent adverse eventsHedgehog pathway inhibitor vismodegibAccess StudyAdvanced BCC patientsPathogenesis of BCCRECIST measurable diseaseMedian disease durationPhase II studySerious adverse eventsSignificant clinical activityAcceptable safety profileEffective treatment optionBasal cell carcinomaClass small-molecule inhibitorEvaluable patientsStable diseaseSafety, pharmacokinetics, and antitumor activity of MEDI-573, an investigational monoclonal antibody that targets IGF-I and IGF-II, in adult patients with advanced solid tumors.
Haluska P, Menefee M, Plimack E, Rosenberg J, Northfelt D, LaVallee T, Huang W, Yu X, Viner J, LoRusso P. Safety, pharmacokinetics, and antitumor activity of MEDI-573, an investigational monoclonal antibody that targets IGF-I and IGF-II, in adult patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: tps2618-tps2618. DOI: 10.1200/jco.2012.30.15_suppl.tps2618.Peer-Reviewed Original ResearchMEDI-573Advanced solid tumorsSolid tumorsAdult patientsGlucose homeostasisDose levelsDrug-related adverse eventsMedian age 64 yearsAdequate organ functionIGF-I/-IIInvestigational monoclonal antibodyAntitumor activityAcceptable safety profileAdvanced bladder cancerAge 64 yearsKarnofsky statusQ3W dosingStable diseaseAdverse eventsSafety profileIGF-IIBladder cancerSerum glucoseSerious toxicityIGF-1R