2024
First-in-human phase 1 dose-escalation results with livmoniplimab, an antibody targeting the GARP:TGF-ß1 complex, as monotherapy and in combination with the anti–PD-1 antibody budigalimab in patients with advanced solid tumors
Shimizu T, Powderly J, Razak A, LoRusso P, Miller K, Kao S, Kongpachith S, Tribouley C, Graham M, Stoll B, Patel M, Sahtout M, Blaney M, Leibman R, Golan T, Tolcher A. First-in-human phase 1 dose-escalation results with livmoniplimab, an antibody targeting the GARP:TGF-ß1 complex, as monotherapy and in combination with the anti–PD-1 antibody budigalimab in patients with advanced solid tumors. Frontiers In Oncology 2024, 14: 1376551. DOI: 10.3389/fonc.2024.1376551.Peer-Reviewed Original ResearchAdvanced solid tumorsDose-escalation phaseDose escalationSolid tumorsSurface of regulatory T cellsRecommended phase 2 doseSuppress antitumor immune responsesCombination therapy cohortsDose-proportional PKMonotherapy-treated patientsPhase 2 doseMedian response durationAntitumor immune responseDose-limiting toxicityTherapy-treated patientsRegulatory T cellsMaximum administered doseFirst-in-humanDose escalation resultsGlycoprotein A repetitionsPromote tumor growthBlood biomarker dataDose expansionPretreated patientsEscalating doses
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