2024
Results from phase 1a/1b analyses of TTX-080, a first in class HLA-G antagonist, in combination with cetuximab in patients (pts) with metastatic colorectal cancer and head and neck squamous cell carcinoma.
Ulahannan S, Marron T, Park H, Kaczmar J, Stephenson R, Lakhani N, Durm G, Grewal J, El-Khoueiry A, Luke J, Beers C, Murugappan S, LoRusso P, Adkins D, Hecht J. Results from phase 1a/1b analyses of TTX-080, a first in class HLA-G antagonist, in combination with cetuximab in patients (pts) with metastatic colorectal cancer and head and neck squamous cell carcinoma. Journal Of Clinical Oncology 2024, 42: 2524-2524. DOI: 10.1200/jco.2024.42.16_suppl.2524.Peer-Reviewed Original ResearchHead and neck squamous cell carcinomaMetastatic colorectal cancerNeck squamous cell carcinomaSquamous cell carcinomaPreliminary efficacy dataCell carcinomaColorectal cancerEfficacy dataSolid tumor cohortTreatment-related AEsImmune cell changesAnti-tumor activityStandard of careRandomized controlled studyDose escalationEscalating dosesHLA-G.Peripheral bloodTumor cohortsSolid tumorsDecreased appetiteAST increaseBlood samplesCell changesQ3W
2020
404 ALX148, a CD47 blocker, in combination with standard chemotherapy and antibody regimens in patients with gastric/gastroesophageal junction (GC) cancer and head and neck squamous cell carcinoma (HNSCC)
Lee K, Chung H, Kim W, Chow L, Lakhani N, Messersmith W, Bang Y, LoRusso P, Fanning P, Squifflet P, Jin F, Forgie A, Wan H, Pons J, Randolph S, Gainor J. 404 ALX148, a CD47 blocker, in combination with standard chemotherapy and antibody regimens in patients with gastric/gastroesophageal junction (GC) cancer and head and neck squamous cell carcinoma (HNSCC). 2020, a245.2-a246. DOI: 10.1136/jitc-2020-sitc2020.0404.Peer-Reviewed Original Research
2019
CX-072, a PD-L1 Probody therapeutic, as monotherapy in patients with advanced solid tumors: Preliminary results of PROCLAIM-CX-072.
Naing A, Thistlethwaite F, Spira A, Garcia-Corbacho J, Randhawa M, Eskens F, O'Neil B, Lavernia J, Uboha N, Hamid O, El-Khoueiry A, Benson B, Garner W, Huels V, Arkenau H, LoRusso P. CX-072, a PD-L1 Probody therapeutic, as monotherapy in patients with advanced solid tumors: Preliminary results of PROCLAIM-CX-072. Journal Of Clinical Oncology 2019, 37: 2513-2513. DOI: 10.1200/jco.2019.37.15_suppl.2513.Peer-Reviewed Original ResearchCutaneous squamous cell carcinomaSquamous cell carcinomaSmall bowel adenocarcinomaCX-072Advanced solid tumorsAdverse eventsSolid tumorsPD-L1Cell carcinomaSkin lesionsAnti-programmed cell death ligand-1 (PD-L1) immunotherapiesGrade 3/4 treatment-related adverse eventsAnal squamous cell carcinomaDeath ligand 1 (PD-L1) immunotherapyStandard curative treatment optionsTreatment-related adverse eventsTriple-negative breast cancerAnti-CTLA4 treatmentPhase 1/2a studyMedian treatment durationCurative treatment optionPD-L1 expressionUnresectable solid tumorsPrior regimensBowel adenocarcinomaA phase I/Ib multicenter study to evaluate the humanized anti-CD73 antibody, CPI-006, as a single agent, in combination with CPI-444, and in combination with pembrolizumab in adult patients with advanced cancers.
Mobasher M, Miller R, Kwei L, Strahs D, Das V, Luciano G, Powderly J, Merchan J, Barve M, LoRusso P, Tripathi A, Luke J. A phase I/Ib multicenter study to evaluate the humanized anti-CD73 antibody, CPI-006, as a single agent, in combination with CPI-444, and in combination with pembrolizumab in adult patients with advanced cancers. Journal Of Clinical Oncology 2019, 37: tps2646-tps2646. DOI: 10.1200/jco.2019.37.15_suppl.tps2646.Peer-Reviewed Original ResearchSingle agentCD73 antibodyTumor growthNon-small cell lungAdequate organ functionAnti-CD73 antibodiesOpen-label trialTreatment of patientsRenal cell carcinomaSelective A2AR antagonistNumber of malignanciesKnockout mice exhibitTriple-negative breastEligible patientsMeasurable diseaseLabel trialAdult patientsStandard therapyAdvanced cancerCD73 expressionImmunosuppressive adenosineMulticenter studyUrothelial bladderCell carcinomaCell lungA phase I study of ALX148, a CD47 blocker, in combination with established anticancer antibodies in patients with advanced malignancy.
Chow L, Gainor J, Lakhani N, Chung H, Lee K, Lee J, LoRusso P, Bang Y, Hodi F, Fanning P, Zhao Y, Jin F, Wan H, Pons J, Randolph S, Messersmith W. A phase I study of ALX148, a CD47 blocker, in combination with established anticancer antibodies in patients with advanced malignancy. Journal Of Clinical Oncology 2019, 37: 2514-2514. DOI: 10.1200/jco.2019.37.15_suppl.2514.Peer-Reviewed Original ResearchCheckpoint inhibitorsImmune responseNon-small cell lung cancerPK/PD characteristicsNeck squamous cell carcinomaGastroesophageal junction cancerCell lung cancerSquamous cell carcinomaHost immune responseData cutoffAdvanced malignanciesAdverse eventsJunction cancerObjective responseRefractory diseaseTumor histologyExcellent tolerabilityCell carcinomaPharmacodynamic markersLung cancerImmune cellsAnticancer antibodiesAST increasePatientsALT increase
2017
Dose escalation results from a first-in-human, phase 1 study of the glucocorticoid-induced TNF receptor-related protein (GITR) agonist AMG 228 in patients (Pts) with advanced solid tumors.
Tran B, Carvajal R, Marabelle A, Patel S, LoRusso P, Rasmussen E, Juan G, Upreti V, Ngarmchamnanrith G, Schöffski P. Dose escalation results from a first-in-human, phase 1 study of the glucocorticoid-induced TNF receptor-related protein (GITR) agonist AMG 228 in patients (Pts) with advanced solid tumors. Journal Of Clinical Oncology 2017, 35: 2521-2521. DOI: 10.1200/jco.2017.35.15_suppl.2521.Peer-Reviewed Original ResearchGlucocorticoid-induced TNF receptor-related proteinAdvanced solid tumorsDose-limiting toxicityPhase 1 studyAdverse eventsSolid tumorsObjective responseDose escalationCell carcinomaNon-small cell lung cancerRefractory advanced colorectal cancerTreatment-emergent adverse eventsHuman IgG1 monoclonal antibodyPhase 2 doseUrothelial transitional cell carcinomaAdvanced colorectal cancerRegulatory T cellsCell lung cancerSquamous cell carcinomaTransitional cell carcinomaDose-escalation resultsT cell activationReceptor-related proteinPopulation of ptsIgG1 monoclonal antibody
2014
Vismodegib in the treatment of patients with metastatic basal cell carcinoma (mBCC) and distant metastases: Survival in the pivotal phase II and phase I studies.
Lewis K, Sekulic A, Hauschild A, Migden M, Oro A, LoRusso P, Rudin C, Dirix L, Solomon J, Hainsworth J, Williams S, Hou J, Von Hoff D. Vismodegib in the treatment of patients with metastatic basal cell carcinoma (mBCC) and distant metastases: Survival in the pivotal phase II and phase I studies. Journal Of Clinical Oncology 2014, 32: 9012-9012. DOI: 10.1200/jco.2014.32.15_suppl.9012.Peer-Reviewed Original Research
2012
Open-label extension study of the RNAi therapeutic ALN-VSP02 in cancer patients responding to therapy.
Alsina M, Tabernero J, Shapiro G, Burris H, Infante J, Weiss G, Cervantes-Ruiperez A, Gounder M, Paz-Ares L, Falzone R, Hill J, Cehelsky J, Vaishnaw A, Gollob J, LoRusso P. Open-label extension study of the RNAi therapeutic ALN-VSP02 in cancer patients responding to therapy. Journal Of Clinical Oncology 2012, 30: 3062-3062. DOI: 10.1200/jco.2012.30.15_suppl.3062.Peer-Reviewed Original ResearchStable diseasePartial responseExtension studyAdverse eventsEndometrial cancerCancer patientsCell carcinomaOpen-label extension studyNeck squamous cell carcinomaMore prior therapiesOngoing partial responseSafety/tolerabilityUnconfirmed partial responseEndometrial cancer patientsPhase II trialMonths of treatmentPhase I trialPhase 1 trialFavorable safety profileSquamous cell carcinomaTime of enrollmentPancreatic neuroendocrine tumorsVascular endothelial growth factorYears of treatmentRenal cell carcinoma
2006
A phase I dose escalation trial of ispinesib (SB-715992) administered days 1–3 of a 21-day cycle in patients with advanced solid tumors
Heath E, Alousi A, Eder J, Valdivieso M, Vasist L, Appleman L, Bhargava P, Colevas A, Lorusso P, Shapiro G. A phase I dose escalation trial of ispinesib (SB-715992) administered days 1–3 of a 21-day cycle in patients with advanced solid tumors. Journal Of Clinical Oncology 2006, 24: 2026-2026. DOI: 10.1200/jco.2006.24.18_suppl.2026.Peer-Reviewed Original ResearchGrade 4 neutropeniaAdvanced solid tumorsDose levelsDay 1Phosphohistone 3Solid tumorsGrade 3 febrile neutropeniaMultiple murine tumor modelsGrade 1 fatigueGrade 3 neutropeniaToxicity of myelosuppressionGrade 3/4 toxicitiesSerial tumor biopsiesRenal cell carcinomaMurine tumor modelsKinesin spindle proteinPreliminary pharmacokinetic dataSignificant antitumor activityNovel cytotoxic agentsEvaluable patientsFebrile neutropeniaMTD cohortStable diseaseEscalation trialCell carcinomaA phase I study of a novel spectrum selective kinase inhibitor (SSKI), XL880, administered orally in patients (pts) with advanced solid tumors (STs)
Eder J, Appleman L, Heath E, Malburg L, Zhu A, Pilat M, Shapiro G, Lorusso P. A phase I study of a novel spectrum selective kinase inhibitor (SSKI), XL880, administered orally in patients (pts) with advanced solid tumors (STs). Journal Of Clinical Oncology 2006, 24: 3041-3041. DOI: 10.1200/jco.2006.24.18_suppl.3041.Peer-Reviewed Original ResearchConsecutive daily dosesAdvanced solid tumorsDaily dosesSolid tumorsSingle doseReceptor tyrosine kinasesSmall-molecule MET inhibitorTerminal half-life valuesGrade 2 hypertensionPapillary renal cell carcinomaSystemic drug exposurePeak plasma levelsRenal cell carcinomaTumor-associated vasculatureHepatocyte growth factor receptorGrowth factor receptorPharmacokinetic samplingPK samplingPartial responseRepeat dosingCell carcinomaMinor responsePlasma levelsDrug exposureMET inhibitors
1988
Chemotherapy for paranasal sinus carcinoma. A 10‐year experience at Wayne state university
Lorusso P, Tapazoglou E, Kish J, Ensley J, Cummings G, Kelly J, Al‐Sarraf M. Chemotherapy for paranasal sinus carcinoma. A 10‐year experience at Wayne state university. Cancer 1988, 62: 1-5. PMID: 2454717, DOI: 10.1002/1097-0142(19880701)62:1<1::aid-cncr2820620102>3.0.co;2-f.Peer-Reviewed Original ResearchConceptsUntreated patientsRecurrent diseaseMedian survivalRole of chemotherapyMajority of patientsManagement of patientsParanasal sinus carcinomaSquamous cell carcinomaOverall response rateResponse 3 monthsAdjuvant chemotherapyEvaluable patientsMeasurable diseaseParanasal cancerPatients 88Predominant toxicityCNS involvementRenal impairmentAdvanced patientsMetastatic diseaseMale patientsRecurrent patientsSinus carcinomaFemale patientsCell carcinoma