2024
1000MO A phase I/II, open-label study of the novel checkpoint IGSF8 inhibitor GV20-0251 in patients with advanced solid tumors
Wentzel K, Peguero J, Kummar S, Lorusso P, Mehnert J, Spira A, Naing A, Hamid O, Mehmi I, Benhadji K, Alland L, Hu X, Xiao H, Bao X, Chen J, Gong Y, Liu X. 1000MO A phase I/II, open-label study of the novel checkpoint IGSF8 inhibitor GV20-0251 in patients with advanced solid tumors. Annals Of Oncology 2024, 35: s680-s681. DOI: 10.1016/j.annonc.2024.08.1059.Peer-Reviewed Original Research
2023
161TiP A phase I/II, open-label study of an anti-ILT2 (LILRB1) antibody, SAR444881, administered alone and in combination with pembrolizumab, with or without chemotherapy, or cetuximab in patients with advanced solid tumors
Perets R, Stemmer S, Geva R, Golan T, Fakih M, Cohen J, Lieu C, Jin Z, Lorusso P, Ashtamker N, Friedman I, Hakim M, Crawford N, Perez R, Agarwal M, Abbadessa G, Wu M, Lin J, Deantonio C, Borad M. 161TiP A phase I/II, open-label study of an anti-ILT2 (LILRB1) antibody, SAR444881, administered alone and in combination with pembrolizumab, with or without chemotherapy, or cetuximab in patients with advanced solid tumors. Immuno-Oncology Technology 2023, 20: 100672. DOI: 10.1016/j.iotech.2023.100672.Peer-Reviewed Original ResearchMirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose expansion results.
Carneiro B, Perets R, Dowlati A, LoRusso P, Yonemori K, He L, Munasinghe W, Noorani B, Johnson E, Zugazagoitia J. Mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose expansion results. Journal Of Clinical Oncology 2023, 41: 3027-3027. DOI: 10.1200/jco.2023.41.16_suppl.3027.Peer-Reviewed Original ResearchNon-small cell lung cancerSmall cell lung cancerOverall response rateCommon adverse eventsRefractory solid tumorsCell lung cancerSCLC cohortBest overall responseAdverse eventsMonotherapy cohortTaxane therapyLung cancerSolid tumorsConfirmed overall response rateDose-expansion phaseOngoing phase 1Phase 2 dosePrior taxane therapyTolerable safety profileDisease control rateGrade 3/4 neutropeniaOpen-label studyDose-escalation phasePhase 1 studySingle-agent activity
2022
Phase 1 trial of TIM-3 inhibitor cobolimab monotherapy and in combination with PD-1 inhibitors nivolumab or dostarlimab (AMBER).
Falchook G, Ribas A, Davar D, Eroglu Z, Wang J, Luke J, Hamilton E, Di Pace B, Wang T, Ghosh S, Dhar A, Borgovan T, Waszak A, LoRusso P. Phase 1 trial of TIM-3 inhibitor cobolimab monotherapy and in combination with PD-1 inhibitors nivolumab or dostarlimab (AMBER). Journal Of Clinical Oncology 2022, 40: 2504-2504. DOI: 10.1200/jco.2022.40.16_suppl.2504.Peer-Reviewed Original ResearchTreatment-related treatment-emergent adverse eventsNon-small cell lung cancerPD-1 inhibitor nivolumabTreatment-emergent adverse eventsTumor-infiltrating T cellsPreliminary anti-tumor activityPhase 2 doseOpen-label studyPD-1 inhibitorsAdvanced solid tumorsPhase 2 studyDose-proportional mannerPhase 1 trialT cell suppressionCell lung cancerTherapeutic dose rangeMost common cancersAnti-tumor activityDose delaysPrior therapyInhibitor nivolumabPrimary endpointTim-3Adverse eventsPeritoneal mesothelioma
2021
A phase Ib study of xentuzumab plus abemaciclib and fulvestrant in patients (pts) with advanced hormone receptor-positive (HR+), HER2-negative breast cancer (BC) with visceral or non-visceral disease.
Yee D, LoRusso P, Sablin M, Prat A, Stradella A, Utriainen M, Oliveira M, Yonemori K, Naito Y, Hardebeck M, Puig M, Hu J, Biyukov T, Iwata H. A phase Ib study of xentuzumab plus abemaciclib and fulvestrant in patients (pts) with advanced hormone receptor-positive (HR+), HER2-negative breast cancer (BC) with visceral or non-visceral disease. Journal Of Clinical Oncology 2021, 39: 1057-1057. DOI: 10.1200/jco.2021.39.15_suppl.1057.Peer-Reviewed Original ResearchDisease control rateNon-visceral diseaseEndocrine therapyBreast cancerVisceral metastasesProgression-free survival benefitHER2-negative breast cancerDisease controlDose-finding cohortMost common AEsMedian treatment durationOpen-label studyPhase Ib studyPhase II doseNon-measurable diseaseHypo/hyperglycemiaCyclin-dependent kinase 4Advanced hormoneCommon AEsPFS ratesExpansion cohortPostmenopausal womenPrimary endpointSecondary endpointsMedian durationA phase 1b, open-label, dose-escalation study to evaluate camidanlumab tesirine (Cami) as monotherapy in patients (pts) with advanced solid tumors.
Puzanov I, LoRusso P, Papadopoulos K, Chen C, LeBruchec Y, He X, Cousin T, Havenith K, Boni J, Bendell J. A phase 1b, open-label, dose-escalation study to evaluate camidanlumab tesirine (Cami) as monotherapy in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2021, 39: 2556-2556. DOI: 10.1200/jco.2021.39.15_suppl.2556.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsAdvanced solid tumorsDisease control rateSolid tumorsDose escalationGrade treatment-emergent adverse eventsNon-small cell lung cancerTumor-specific immune responsesTriple-negative breast cancerDose-escalation partPhase 2 dosePrior systemic therapyAntitumor activityMedian treatment durationOpen-label studyDose-escalation studyPhase 1b trialPrimary tumor typeRegulatory T cellsCell lung cancerPreliminary antitumor activityPK/PD dataRenal cell carcinomaSolid tumor modelsAntibody-drug conjugates
2015
A phase 1, open-label study to evaluate the safety and pharmacokinetics of the anti ErbB3 antibody, KTN3379, alone or in combination with targeted therapies in patients with advanced tumors.
Bauer T, Infante J, Eder J, LoRusso P, LaVallee T, Gedrich R, Sidor C, Falchook G. A phase 1, open-label study to evaluate the safety and pharmacokinetics of the anti ErbB3 antibody, KTN3379, alone or in combination with targeted therapies in patients with advanced tumors. Journal Of Clinical Oncology 2015, 33: 2598-2598. DOI: 10.1200/jco.2015.33.15_suppl.2598.Peer-Reviewed Original Research
2007
AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumors
Mita A, Wang D, Takimoto C, Malseed E, Nguyen L, Rasmussen E, Storgard C, LoRusso P. AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 14033-14033. DOI: 10.1200/jco.2007.25.18_suppl.14033.Peer-Reviewed Original ResearchDose-limiting toxicityAMG 386Advanced solid tumorsComplete responsePK profilesAdult patientsSolid tumorsMedian age 59.5 yearsAntitumor activityOpen-label studyGemcitabine/cisplatinFurther clinical studiesFormation of antibodiesTumor response dataSerious AEsCancer refractoryFOLFOX-4Stable diseaseProgressive diseaseWeekly administrationTumor responseWeek 16Bladder cancerDisease progressionWeek 8