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
2017
Phase 1 safety of ICOS agonist antibody JTX-2011 alone and with nivolumab (nivo) in advanced solid tumors; predicted vs observed pharmacokinetics (PK) in ICONIC.
Burris H, Callahan M, Tolcher A, Kummar S, Falchook G, Pachynski R, Tykodi S, Gibney G, Seiwert T, Gainor J, LoRusso P, Hilbert J, Apgar J, Hua F, Burke J, Lazaro M, Clancy M, Ding B, Trehu E, Yap T. Phase 1 safety of ICOS agonist antibody JTX-2011 alone and with nivolumab (nivo) in advanced solid tumors; predicted vs observed pharmacokinetics (PK) in ICONIC. Journal Of Clinical Oncology 2017, 35: 3033-3033. DOI: 10.1200/jco.2017.35.15_suppl.3033.Peer-Reviewed Original ResearchAdverse eventsTarget engagementPK dataCD4 T effector cellsGrade 3 adverse eventsGrade 1Inducible Co-StimulatorPhase 1 SafetyPrior systemic therapyAdvanced solid tumorsDose limiting toxicitiesT effector cellsPhase 1 studyHours post infusionAgonist monoclonal antibodyNon-tumor tissuesTriple-negative breastQuantitative systems pharmacology modelExposure increasesPreclinical potencyQ21 daysNeck painInfusion reactionsRegulatory cellsSystemic therapy