2021
Safety and preliminary efficacy from the phase 1 portion of MasterKey-01: A First-in-human dose-escalation study to determine the recommended phase 2 dose (RP2D), pharmacokinetics (PK) and preliminary antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients (pts) with advanced solid malignancies.
Schram A, Ahnert J, Patel M, Jauhari S, Sachdev J, Zhu V, LoRusso P, Nguyen D, Le X, O'Connor M, Waters N, Cook C, Witt K, Humphrey R, Janne P, Hamilton E. Safety and preliminary efficacy from the phase 1 portion of MasterKey-01: A First-in-human dose-escalation study to determine the recommended phase 2 dose (RP2D), pharmacokinetics (PK) and preliminary antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients (pts) with advanced solid malignancies. Journal Of Clinical Oncology 2021, 39: 3086-3086. DOI: 10.1200/jco.2021.39.15_suppl.3086.Peer-Reviewed Original ResearchFE cohortHER2 amplificationSolid tumorsHuman dose-escalation studyDose-escalation cohortsManageable safety profilePhase 2 doseAdvanced solid malignanciesAdvanced solid tumorsDose-escalation studyMetastatic solid tumorsPreliminary antitumor activityPhase 1 portionAnti-tumor activityTumor growth inhibitionBID cohortQD scheduleEGFR/HER2Adverse eventsEscalation cohortsPartial responseProgressive diseaseStandard therapySafety profilePreliminary efficacy
2013
Phase I, first-in-human, open-label, dose-escalation study of U3-1565, a fully human anti-HB-EGF monoclonal antibody, in patients with advanced solid tumors.
Moore K, Bendell J, Olszanski A, Desai M, Jansen M, Scheyer R, Senaldi G, LoRusso P. Phase I, first-in-human, open-label, dose-escalation study of U3-1565, a fully human anti-HB-EGF monoclonal antibody, in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2519-2519. DOI: 10.1200/jco.2013.31.15_suppl.2519.Peer-Reviewed Original ResearchAdvanced solid tumorsYear old femaleAnti-tumor activitySolid tumorsMonoclonal antibodiesDose level cohortsDose-expansion studyDose-escalation studyBi-exponential dispositionEpidermal growth factor-like growth factorEGF family membersTumor growth inhibitionFactor-like growth factorG1 toxicityProgressive diseaseAnti-angiogenesis activityStandard treatmentPatientsRelated AEsExtension phasePhase IGrowth factorLevel cohortsWeeksWeekly
2009
A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765, a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced solid tumors
LoRusso P, Markman B, Tabernero J, Shazer R, Nguyen L, Heath E, Patnaik A, Papadopoulos K. A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765, a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2009, 27: 3502-3502. DOI: 10.1200/jco.2009.27.15_suppl.3502.Peer-Reviewed Original ResearchAdverse eventsPhase I dose-escalation studyI dose-escalation studyDurable stable diseaseElevated hepatic transaminasesFood-induced increaseElevated liver enzymesNausea/vomitingSerious adverse eventsAdvanced solid tumorsDose-escalation studyPI3K pathway inhibitionClass I PI3K isoformsTumor growth inhibitionPI3K pathwayPharmacodynamic modulationQD regimenStable diseaseBID regimenHepatic transaminasesNeurological complaintsRepeat dosingPI3K isoformsPlasma insulinTolerable doses