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
2021
498 Evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with head and neck squamous cell carcinoma (HNSCC) and with gastric/gastroesophageal cancer (GC); ASPEN-01
Lee K, Chung H, Kim T, Lakhani N, Messersmith W, Santana-Davila R, Kim W, LoRusso P, Bang Y, Chow L, Fanning P, Squifflet P, Jin F, Forgie A, Wan H, Pons J, Randolph S, Gainor J. 498 Evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with head and neck squamous cell carcinoma (HNSCC) and with gastric/gastroesophageal cancer (GC); ASPEN-01. Journal For ImmunoTherapy Of Cancer 2021, 9: a530-a530. DOI: 10.1136/jitc-2021-sitc2021.498.Peer-Reviewed Original ResearchTreatment-related AEsGastroesophageal cancerCheckpoint inhibitorsAdvanced HNSCCEvaluable patientsHER2-positive gastroesophageal cancerNeck squamous cell carcinomaCytotoxic chemotherapy regimensLong-term PFSGastroesophageal junction cancerPhase 1 studyFavorable safety profileHER2-positive advanced gastricSquamous cell carcinomaAdaptive antitumor immunityWarrants further evaluationChemotherapy regimensPrimary endpointAdvanced gastricAdvanced malignanciesJunction cancerLine therapyMethods PatientsStandard chemotherapyAntitumor immunity484 Preliminary efficacy of the IL-15 superagonist SO-C101 in combination with pembrolizumab in patients with advanced/metastatic solid tumors
Garralda E, Galvao V, Champiat S, LoRusso P, Grell P, Naing A, Janku F, Sachse R, Bechard D, Kiemle-Kallee J, Marabelle A, Garralda E. 484 Preliminary efficacy of the IL-15 superagonist SO-C101 in combination with pembrolizumab in patients with advanced/metastatic solid tumors. Journal For ImmunoTherapy Of Cancer 2021, 9: a514-a514. DOI: 10.1136/jitc-2021-sitc2021.484.Peer-Reviewed Original ResearchStudy drug-related adverse eventsDrug-related adverse eventsCytokine release syndromeDose-limiting toxicityAdverse eventsCommon study drug-related adverse eventsAnti-programmed cell death protein 1 antibodyGrade 3 cytokine release syndromeSolid tumorsCell death protein 1 antibodyAnti-PD-1 therapyLong-term stable diseaseLocal injection site reactionsSkin squamous cell carcinomaPhase 2 dosePrevious systemic therapyTreatment-related deathsInjection site reactionsMetastatic solid tumorsAdditional clinical benefitDose-escalation designProtective memory responsesProtein 1 antibodySquamous cell carcinomaAvailable safety data502 Recommended phase 2 dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the IL-15 superagonist SO-C101 as monotherapy in patients with advanced/metastatic solid tumors
Marabelle A, Champiat S, Galvao V, Naing A, Janku F, LoRusso P, Grell P, Sachse R, Bechard D, Kiemle-Kallee J, Garralda E. 502 Recommended phase 2 dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the IL-15 superagonist SO-C101 as monotherapy in patients with advanced/metastatic solid tumors. 2021, a534-a534. DOI: 10.1136/jitc-2021-sitc2021.502.Peer-Reviewed Original ResearchPhase 2 doseDose-limiting toxicityAdverse eventsPartial responseStable diseaseTransaminase increaseSolid tumorsDrug-related adverse eventsIL-15 receptor αCutaneous squamous cell carcinomaLocal injection site reactionsPrevious systemic therapyResults Thirty patientsSignificant partial responseTreatment-related deathsCommon adverse eventsFlu-like syndromeRelated adverse eventsInjection site reactionsMetastatic solid tumorsAdditional clinical benefitDose-escalation designSquamous cell carcinomaDose-dependent increaseT cell activation
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 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 antibodyA call for global harmonization of phase I oncology trials: Results from two parallel, first-in-human phase I studies of DS-7423, an oral PI3K/mTOR dual inhibitor in advanced solid tumors conducted in the United States and Japan.
Yokota T, Bendell J, LoRusso P, Tsushima T, Desai V, Kenmotsu H, Watanabe J, Ono A, Murugesan B, Silva J, Naito T, Greenberg J, Kumar P, Wang Y, Jikoh T, Shiga R, Ho A, Gounder M. A call for global harmonization of phase I oncology trials: Results from two parallel, first-in-human phase I studies of DS-7423, an oral PI3K/mTOR dual inhibitor in advanced solid tumors conducted in the United States and Japan. Journal Of Clinical Oncology 2017, 35: 2536-2536. DOI: 10.1200/jco.2017.35.15_suppl.2536.Peer-Reviewed Original ResearchMaximum-tolerated doseBody mass indexAdvanced solid tumorsBody weightPhase IFrequent treatment-related adverse eventsSolid tumorsNon-small cell lung cancerGrade 3 lung infectionHuman Phase I StudyTreatment-related adverse eventsCorresponding phase IGrade 3 dehydrationGrade 3 fatigueGrade 3 stomatitisGrade 4 hyperglycemiaPhase 2 doseGrade 3 rashCell lung cancerPhase I studiesSquamous cell carcinomaPI3K/mTOR dual inhibitorPI3K/mTORMTOR dual inhibitorStable disease
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
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