2023
Mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose expansion results.
Carneiro B, Perets R, Dowlati A, LoRusso P, Yonemori K, He L, Munasinghe W, Noorani B, Johnson E, Zugazagoitia J. Mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose expansion results. Journal Of Clinical Oncology 2023, 41: 3027-3027. DOI: 10.1200/jco.2023.41.16_suppl.3027.Peer-Reviewed Original ResearchNon-small cell lung cancerSmall cell lung cancerOverall response rateCommon adverse eventsRefractory solid tumorsCell lung cancerSCLC cohortBest overall responseAdverse eventsMonotherapy cohortTaxane therapyLung cancerSolid tumorsConfirmed overall response rateDose-expansion phaseOngoing phase 1Phase 2 dosePrior taxane therapyTolerable safety profileDisease control rateGrade 3/4 neutropeniaOpen-label studyDose-escalation phasePhase 1 studySingle-agent activity
2021
A first-in-human study of mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose escalation results.
Tolcher A, Carneiro B, Dowlati A, Razak A, Chae Y, Villella J, Coppola S, Englert S, Phillips A, Souers A, Salman Z, Penugonda S, Powderly J, LoRusso P. A first-in-human study of mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose escalation results. Journal Of Clinical Oncology 2021, 39: 3015-3015. DOI: 10.1200/jco.2021.39.15_suppl.3015.Peer-Reviewed Original ResearchRefractory solid tumorsAdverse eventsCell lung cancerSolid tumorsLymphocyte countLung cancerNon-small cell lung cancerSmall cell lung cancerMedian age 62 yearsCommon adverse eventsDose-expansion phasePhase 2 dosePrior systemic therapyTolerable safety profileFatal adverse eventsFatal cardiac arrestOverall response rateAge 62 yearsDose-escalation resultsAnti-tumor activityECOG 0ECOG 1RECIST v1.1Taxane therapyMedian duration
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
2015
Clinical activity of AMG 337, an oral MET kinase inhibitor, in adult patients (pts) with MET-amplified gastroesophageal junction (GEJ), gastric (G), or esophageal (E) cancer.
Kwak E, LoRusso P, Hamid O, Janku F, Kittaneh M, Catenacci D, Chan E, Bekaii-Saab T, Amore B, Hwang Y, Tang R, Ngarmchamnanrith G, Hong D. Clinical activity of AMG 337, an oral MET kinase inhibitor, in adult patients (pts) with MET-amplified gastroesophageal junction (GEJ), gastric (G), or esophageal (E) cancer. Journal Of Clinical Oncology 2015, 33: 1-1. DOI: 10.1200/jco.2015.33.3_suppl.1.Peer-Reviewed Original ResearchAMG 337MET kinase inhibitorGastroesophageal junctionGI cancersClinical activityCommon treatment-emergent AEsKinase inhibitorsAdequate organ functionDose-expansion phaseSubset of ptsTreatment-emergent AEsAdvanced solid tumorsDose-limiting toxicityKey eligibility criteriaAmplification/mutationMeasurable diseaseAdult patientsComplete responsePartial responseDose escalationMedian ageGI tumorsAE profileEsophageal cancerMET pathway