2024
Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103)
Garralda E, Oh Y, Italiano A, Bedard P, Delord J, Calvo E, LoRusso P, Wainberg Z, Cervantes A, Rodriguez‐Vida A, Shemesh C, Sane R, Mendus D, Ding H, Hendricks R, Meng R, Cho B, Kim T, Wu B. Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103). The Journal Of Clinical Pharmacology 2024, 64: 544-554. PMID: 38105505, DOI: 10.1002/jcph.2397.Peer-Reviewed Original ResearchSolid tumorsMixed solid tumorsDose-proportional mannerDrug-drug interactionsSlower elimination phaseSequential dosingInter-individual variabilityIntravenous infusionSystemic exposureImmunogenicity assessmentAtezolizumabHuman studiesElimination phasePK dataPK profilesPK propertiesPatientsMonoclonal antibodiesSerum samplesPharmacokineticsDays/Multiple timepointsSingle timepointGeometric meanQ4W
2023
First-in-human study of oleclumab, a potent, selective anti-CD73 monoclonal antibody, alone or in combination with durvalumab in patients with advanced solid tumors
Bendell J, LoRusso P, Overman M, Noonan A, Kim D, Strickler J, Kim S, Clarke S, George T, Grimison P, Barve M, Amin M, Desai J, Wise-Draper T, Eck S, Jiang Y, Khan A, Wu Y, Martin P, Cooper Z, Elgeioushi N, Mueller N, Kumar R, Patel S. First-in-human study of oleclumab, a potent, selective anti-CD73 monoclonal antibody, alone or in combination with durvalumab in patients with advanced solid tumors. Cancer Immunology, Immunotherapy 2023, 72: 2443-2458. PMID: 37016126, PMCID: PMC10264501, DOI: 10.1007/s00262-023-03430-6.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsPancreatic ductal adenocarcinomaColorectal cancerExpansion cohortHuman studiesResponse rateAnti-CD73 monoclonal antibodyProgression-free survival ratesTumor cellsMonoclonal antibodiesCommon being fatigueManageable safety profileObjective response rateAdvanced colorectal cancerAdvanced solid tumorsCell lung cancerPeripheral T cellsDate of registrationCD73 enzymatic activityAdverse eventsEscalation cohortsLocal immunosuppressionCD73 expressionSafety profileLung cancer
2016
Antibody–Drug Conjugates (ADCs) in Clinical Development
McLaughlin J, LoRusso P. Antibody–Drug Conjugates (ADCs) in Clinical Development. 2016, 321-344. DOI: 10.1002/9781119060727.ch13.Peer-Reviewed Original ResearchAntibody-drug conjugatesCytotoxic agentsMonoclonal antibodiesLocal immune responseFavorable safety profileConventional cytotoxic chemotherapyConventional cytotoxic agentsDifferent antibody–drug conjugatesImmune-stimulating agentsAnti-neoplastic agentsCytotoxic chemotherapySafety profileCancer patientsIL-2Clinical trialsImmune responseClinical developmentOncologist's abilityImproved efficacyPhase IDrug conjugatesAntibodiesEfficacyTarget effectsToxicity
2013
Phase I, first-in-human, open-label, dose-escalation study of U3-1565, a fully human anti-HB-EGF monoclonal antibody, in patients with advanced solid tumors.
Moore K, Bendell J, Olszanski A, Desai M, Jansen M, Scheyer R, Senaldi G, LoRusso P. Phase I, first-in-human, open-label, dose-escalation study of U3-1565, a fully human anti-HB-EGF monoclonal antibody, in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2519-2519. DOI: 10.1200/jco.2013.31.15_suppl.2519.Peer-Reviewed Original ResearchAdvanced solid tumorsYear old femaleAnti-tumor activitySolid tumorsMonoclonal antibodiesDose level cohortsDose-expansion studyDose-escalation studyBi-exponential dispositionEpidermal growth factor-like growth factorEGF family membersTumor growth inhibitionFactor-like growth factorG1 toxicityProgressive diseaseAnti-angiogenesis activityStandard treatmentPatientsRelated AEsExtension phasePhase IGrowth factorLevel cohortsWeeksWeekly
2012
609 A Phase 1 Study of MEDI-573, an Investigational Monoclonal Antibody That Targets IGF-I and IGF-II: Safety, Pharmacokinetics, and Antitumor Activity in Adults with Advanced Solid Tumors
Haluska P, Menefee M, Plimack E, Rosenberg J, Northfelt D, LaVallee T, Huang W, Yu X, Viner J, LoRusso P. 609 A Phase 1 Study of MEDI-573, an Investigational Monoclonal Antibody That Targets IGF-I and IGF-II: Safety, Pharmacokinetics, and Antitumor Activity in Adults with Advanced Solid Tumors. European Journal Of Cancer 2012, 48: 187-188. DOI: 10.1016/s0959-8049(12)72406-1.Peer-Reviewed Original ResearchActivity of insulin growth factor-receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with metastatic refractory adrenocortical carcinoma.
Naing A, LoRusso P, Fu S, Hong D, Chen H, Doyle L, Phan A, Habra M, Kurzrock R. Activity of insulin growth factor-receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with metastatic refractory adrenocortical carcinoma. Journal Of Clinical Oncology 2012, 30: 4639-4639. DOI: 10.1200/jco.2012.30.15_suppl.4639.Peer-Reviewed Original ResearchIGF-1R inhibitorsAdrenocortical carcinomaStable diseaseHuman IgG1 monoclonal antibodyProlonged stable diseaseGrowth factor receptor antibodyEffective systemic chemotherapyGrowth factor 1 receptorInsulin growth factor-1 receptorMTOR inhibitor temsirolimusFactor 1 receptorIgG1 monoclonal antibodyPrior therapyFrequent toxicitiesSystemic chemotherapyMedian agePreclinical dataMedian numberTemsirolimusPatientsCixutumumabMTOR pathwayGrade 1Monoclonal antibodiesCarcinoma
2010
234 A phase 1, open-label, dose-finding study to assess the safety and tolerability of U3 1287 (AMG 888), a human monoclonal antibody targeting HER3 in patients with advanced solid tumors
LoRusso P, Keedy V, Yee L, Oliveira M, Rizvi N, Berlin J, Jin X, Hettmann T, Copigneaux C, Beaupre D. 234 A phase 1, open-label, dose-finding study to assess the safety and tolerability of U3 1287 (AMG 888), a human monoclonal antibody targeting HER3 in patients with advanced solid tumors. European Journal Of Cancer Supplements 2010, 8: 76. DOI: 10.1016/s1359-6349(10)71939-x.Peer-Reviewed Original Research
2008
406 POSTER IMC-18F1, a recombinant human monoclonal antibody (MAb) against the vascular endothelial growth factor receptor-1 (VEGFR-1), in the treatment of patients (pts) with advanced solid malignancies: A Phase 1 study
Krishnamurthi S, Goncalves P, Fox F, Hall N, Rowinsky E, Schwartz J, Youssoufian H, LoRusso P. 406 POSTER IMC-18F1, a recombinant human monoclonal antibody (MAb) against the vascular endothelial growth factor receptor-1 (VEGFR-1), in the treatment of patients (pts) with advanced solid malignancies: A Phase 1 study. European Journal Of Cancer Supplements 2008, 6: 127-128. DOI: 10.1016/s1359-6349(08)72340-1.Peer-Reviewed Original Research554 POSTER Pharmacokinetic (PK) and pharmacodynamic (PD) results of Phase I studies of IMC-A12, a fully human insulin like growth factor-I receptor IgG1 monoclonal antibody, in patients with advanced solid malignancies
Rothenberg M, Poplin E, LoRusso P, Yu E, Schwartz J, Fox F, Mehnert J, Sandler A, Rowinsky E, Higano C. 554 POSTER Pharmacokinetic (PK) and pharmacodynamic (PD) results of Phase I studies of IMC-A12, a fully human insulin like growth factor-I receptor IgG1 monoclonal antibody, in patients with advanced solid malignancies. European Journal Of Cancer Supplements 2008, 6: 174-175. DOI: 10.1016/s1359-6349(08)72488-1.Peer-Reviewed Original Research
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
2006
648 POSTER A phase I dose-escalation study of weekly IMC-A12, a fully human insulin like growth factor-I receptor (IGF-IR) IgG1 monoclonal antibody (Mab), in patients (pts) with advanced cancer
Higano C, Gordon M, LoRusso P, Fox F, Katz T, Roecker J, Rowinsky E, Youssoufian H. 648 POSTER A phase I dose-escalation study of weekly IMC-A12, a fully human insulin like growth factor-I receptor (IGF-IR) IgG1 monoclonal antibody (Mab), in patients (pts) with advanced cancer. European Journal Of Cancer Supplements 2006, 4: 195. DOI: 10.1016/s1359-6349(06)70653-x.Peer-Reviewed Original Research
1993
Immunohistologic evaluation of invasion-associated proteases in breast carcinoma.
Visscher D, Sarkar F, LoRusso P, Sakr W, Ottosen S, Wykes S, Crissman J. Immunohistologic evaluation of invasion-associated proteases in breast carcinoma. Modern Pathology 1993, 6: 302-6. PMID: 8346178.Peer-Reviewed Original ResearchConceptsBreast carcinomaUrokinase-type plasminogen activatorShort-term recurrence-free survivalCathepsin DNode-positive patientsRecurrence-free survivalProteolytic enzyme expressionHeterogeneous staining patternFree survivalImmunohistologic evaluationMetastatic diseasePositive patientsInflammatory cellsNeoplastic epitheliumExtracellular matrix dissolutionSystematic metastasisClinical aggressivenessMost tumorsTumor componentsMetastatic capacityCryostat sectionsCarcinomaMonoclonal antibodiesStaining patternPlasminogen activator