2021
503 Clinical activity of ICT01, an anti-BTN3A-targeted, γ9δ2-activating mAb, alone and in combination with pembrolizumab in patients with advanced/refractory solid tumors: EVICTION trial
Wermke M, Marabelle A, Jungels C, Bono J, Vey N, Vicier C, Garralda E, Gouill S, LoRusso P, Champiat S, List C, Aguiar V, Wetzko K, Rhunke L, Gassart A, Brune P, Valentin E, Iche M, Olive D, Frohna P. 503 Clinical activity of ICT01, an anti-BTN3A-targeted, γ9δ2-activating mAb, alone and in combination with pembrolizumab in patients with advanced/refractory solid tumors: EVICTION trial. 2021, a535-a535. DOI: 10.1136/jitc-2021-sitc2021.503.Peer-Reviewed Original ResearchΓ9δ2 T cellsCD8 T cellsRefractory solid tumorsSolid tumor patientsT cellsSolid tumorsTumor patientsBroad antitumor immune responseHospital Universitari Vall d’HebronEthics CommitteeT-cell countsAntitumor immune responseTumor-infiltrating lymphocytesNK cell activationPreliminary efficacy dataInstitut Jules BordetDose-dependent increaseSubsequent clinical benefitCytokine level analysisCommon AEsDose cohortsEudraCT numberLow TILsPhase 1/2aSerum cytokines
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 response
2013
A phase I dose-escalation and PK study of continuous oral rucaparib in patients with advanced solid tumors.
Kristeleit R, Shapiro G, LoRusso P, Infante J, Flynn M, Patel M, Tolaney S, Hilton J, Calvert A, Giordano H, Isaacson J, Borrow J, Allen A, Jaw-Tsai S, Burris H. A phase I dose-escalation and PK study of continuous oral rucaparib in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2585-2585. DOI: 10.1200/jco.2013.31.15_suppl.2585.Peer-Reviewed Original ResearchAdvanced solid tumorsOral rucaparibStable diseaseTrough levelsSolid tumorsIntra-patient dose escalationOverall disease control rateTreatment-related adverse eventsOral small-molecule inhibitorDose-proportional PKDurable stable diseaseLow interpatient variabilityPhase 2 doseDisease control rateDose-escalation designDose cohortsBID dosingAdverse eventsObjective responsePK assessmentDose escalationEscalation designControl rateQD dosingStandard treatment
2009
Phase I study combining an IGFR inhibitor (IMC-A12) and an mTOR inhibitor (temsirolimus) in patients with solid tumors or lymphoma
Naing A, LoRusso P, Mills G, Berry D, Doyle L, Rohren E, Burger A, Chen H, Busaidy N, Kurzrock R. Phase I study combining an IGFR inhibitor (IMC-A12) and an mTOR inhibitor (temsirolimus) in patients with solid tumors or lymphoma. Journal Of Clinical Oncology 2009, 27: e14535-e14535. DOI: 10.1200/jco.2009.27.15_suppl.e14535.Peer-Reviewed Original ResearchIMC-A12MTOR inhibitorsDose cohortsSolid tumorsBiologic effectsType I insulin-like growth factor receptorCommon grade 1Dose-escalation cohortsImmunosuppressive agent sirolimusLambda monoclonal antibodySolid tumor histologiesGrade 2 toxicityAdvanced solid tumorsHistory of diabetesI insulin-like growth factor receptorInsulin-like growth factor receptorCombination of temsirolimusGrowth factor receptorStable diseaseEscalation cohortsWeekly doseTumor histologyGrade 3IGFR inhibitorsTherapeutic effect
2007
Phase I study of LY573636-sodium, an acylsulfonamide anti-cancer compound with a novel mechanism of action, administered as 24-hour continuous infusion in patients with advanced solid tumors
Slapak C, LoRusso P, Mendelson D, Sykes A, De Alwis D, Wagner M, Ilaria R, Gordon M. Phase I study of LY573636-sodium, an acylsulfonamide anti-cancer compound with a novel mechanism of action, administered as 24-hour continuous infusion in patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 2542-2542. DOI: 10.1200/jco.2007.25.18_suppl.2542.Peer-Reviewed Original ResearchAnti-cancer compoundsStable diseaseLower total plasma clearanceNovel anti-cancer compoundsGrade 3 hyperbilirubinemiaGrade 4 leukopeniaMaintenance dose regimenGrade 4 thrombocytopeniaAdvanced solid tumorsPhase 2 studyPhase 1 studyContinuous intravenous infusionPhase I studiesSoft tissue sarcomasTotal plasma clearanceCommon DLTDose cohortsDose regimenAlbumin-bound drugsMedian ageTerminal eliminationTissue sarcomasContinuous infusionIntravenous infusionBM suppressionPhase I trial of intravenous 17-allylaminogeldanamycin (A) and oral sorafenib (B) in pretreated advanced malignancy: Plasma Hsp90α induction correlates with clinical benefit
Vaishampayan U, Sausville E, Horiba M, Quinn M, Heilbrun L, Burger A, Ivy P, Li J, Lorusso P. Phase I trial of intravenous 17-allylaminogeldanamycin (A) and oral sorafenib (B) in pretreated advanced malignancy: Plasma Hsp90α induction correlates with clinical benefit. Journal Of Clinical Oncology 2007, 25: 3531-3531. DOI: 10.1200/jco.2007.25.18_suppl.3531.Peer-Reviewed Original ResearchAdvanced malignanciesClinical benefitGrade 3 hand-foot syndromeAdequate organ functionGrade 2 nauseaGrade 3 fatigueResponse-evaluable patientsHand-foot syndromePhase II dosePhase I trialSystemic cancer therapyDose cohortsEvaluable patientsInevaluable patientsNCI-CTEPOral sorafenibStable diseaseB. PatientsClinical responseFoot syndromeLatter patientsMajor toxicityPartial responsePerformance statusStable patientsFirst-in-human study of AMG 655, a pro-apoptotic TRAIL receptor-2 agonist, in adult patients with advanced solid tumors
LoRusso P, Hong D, Heath E, Kurzrock R, Wang D, Hsu M, Goyal L, Wiezorek J, Storgard C, Herbst R. First-in-human study of AMG 655, a pro-apoptotic TRAIL receptor-2 agonist, in adult patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 3534-3534. DOI: 10.1200/jco.2007.25.18_suppl.3534.Peer-Reviewed Original ResearchNon-small cell lung cancerMetabolic partial responseAdvanced solid tumorsPartial responseStable diseaseColorectal cancerHuman studiesSolid tumorsMaximum standardized uptake valueDose-linear kineticsElevated serum lipaseSequential dose cohortsOnly grade 3Cell lung cancerReceptor 2 agonistStandardized uptake valueHuman monoclonal agonist antibodyMonoclonal agonist antibodyAnti-tumor activitySensitive tumor cellsTumor response dataSerious AEsDose cohortsProgressive diseaseUnacceptable toxicity