2023
CBX-12-101: A first-in-human study of CBX-12, an alphalex peptide drug conjugate (PDC) in patients (pts) with advanced or metastatic solid tumors.
Rodriguez Rivera I, Hafez N, Tolcher A, LoRusso P, Wilks S, Tripathy D, Gara M, Pearson P, DeCillis A, Meric-Bernstam F. CBX-12-101: A first-in-human study of CBX-12, an alphalex peptide drug conjugate (PDC) in patients (pts) with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2023, 41: 3087-3087. DOI: 10.1200/jco.2023.41.16_suppl.3087.Peer-Reviewed Original ResearchTreatment-related AEsOvarian cancerBreast cancerFrequent treatment-related AEsHER2-negative breast cancerPlatinum-resistant ovarian cancerDaily x 3Daily x 5Hormone receptor positiveSingle-agent antitumor activityMetastatic solid tumorsPhase 1 trialAnti-drug antibodiesNegative breast cancerAnti-tumor activityAntibody-drug conjugatesFebrile neutropeniaRECIST v1.1WBC decreaseExpansion cohortFIH studiesPlasma PKTumor cell membranesHuman studiesSolid tumors
2012
497P Dose-Escalation Phase I Study of Cabazitaxel (CBZ) + Gemcitabine (GEM) in Patients (PTS) with Metastatic or Unresectable Advanced Solid Malignancy
Rixe O, Puzanov I, LoRusso P, Yin J, Doroumian S, Zhi X, Olszanski A. 497P Dose-Escalation Phase I Study of Cabazitaxel (CBZ) + Gemcitabine (GEM) in Patients (PTS) with Metastatic or Unresectable Advanced Solid Malignancy. Annals Of Oncology 2012, 23: ix170. DOI: 10.1016/s0923-7534(20)33059-3.Peer-Reviewed Original ResearchTreatment-emergent AEsAdministration sequenceFebrile neutropeniaMetastatic castration-resistant prostate cancerDose-escalation phase IAntitumour activityCastration-resistant prostate cancerPhase IPreliminary PK dataAdvanced solid malignanciesGrade 4 neutropeniaAlternative dosing regimensDrug-drug interactionsUnresectable solid tumorsDrug administration sequenceStable diseaseHaematological toxicityTaxane combinationsOverall survivalPartial responseAdvanced cancerDosing regimensGEM 1000Study treatmentTolerable combinationPhase Ib study of CNTO 888 (anti-CCL 2) in combination with chemotherapies for treatment of patients with solid tumors.
Calles A, Brana I, LoRusso P, Yee L, Puchalski T, Seetharam S, Balvers M, De Boer C, Elsayed Y, Calvo E, Tabernero J. Phase Ib study of CNTO 888 (anti-CCL 2) in combination with chemotherapies for treatment of patients with solid tumors. Journal Of Clinical Oncology 2012, 30: 3059-3059. DOI: 10.1200/jco.2012.30.15_suppl.3059.Peer-Reviewed Original ResearchCC chemokine ligand 2Adverse eventsPartial responseArm 1Febrile neutropeniaArm 3Arm 2Arm 4PK profilesGrade 4 febrile neutropeniaGrade 3 neutropeniaPhase Ib studySerious adverse eventsTreatment of patientsBest overall responsePreclinical antitumor activityCEC countsGemcitabine 1000Prior chemotherapyStable diseaseAdvanced diseaseObjective responseStandard chemotherapySurgical resectionHr post treatment
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 carcinoma
1999
Phase II study of CI-958 in colorectal cancer
Shields A, Philip P, LoRusso P, Ferris A, Zalupski M. Phase II study of CI-958 in colorectal cancer. Cancer Chemotherapy And Pharmacology 1999, 43: 162-164. PMID: 9923823, DOI: 10.1007/s002800050878.Peer-Reviewed Original ResearchConceptsAdvanced colorectal cancerColorectal cancerCI-958Patient experienced febrile neutropeniaAcute febrile reactionExperienced febrile neutropeniaPhase II studyPhase II trialStart of treatmentFebrile neutropeniaII trialMetastatic settingII studyMajor toxicityMedian survivalMetastatic diseaseObjective responseFebrile reactionsPatientsCancerDoseTreatmentLeukopeniaNeutropeniaRegimen