2018
Safety and pharmacokinetics of MM-302, a HER2-targeted antibody–liposomal doxorubicin conjugate, in patients with advanced HER2-positive breast cancer: a phase 1 dose-escalation study
Munster P, Krop IE, LoRusso P, Ma C, Siegel BA, Shields AF, Molnár I, Wickham TJ, Reynolds J, Campbell K, Hendriks BS, Adiwijaya BS, Geretti E, Moyo V, Miller KD. Safety and pharmacokinetics of MM-302, a HER2-targeted antibody–liposomal doxorubicin conjugate, in patients with advanced HER2-positive breast cancer: a phase 1 dose-escalation study. British Journal Of Cancer 2018, 119: 1086-1093. PMID: 30361524, PMCID: PMC6219487, DOI: 10.1038/s41416-018-0235-2.Peer-Reviewed Original ResearchConceptsOverall response rateAdverse eventsMM-302Breast cancerAdvanced HER2-positive breast cancerPhase 1 dose-escalation studyPhase 1 dose-escalation trialGrade 3/4 adverse eventsHER2-positive breast cancerAnthracycline-naïve patientsResultsSixty-nine patientsCommon adverse eventsDose-escalation studyDose-escalation trialPalmar-plantar erythrodysesthesiaMetastatic breast cancerFebrile neutropeniaMucosal inflammationPromising efficacyResponse rateTrastuzumabQ3wPatientsMonotherapyNeutropenia
2017
A phase I study of PF-06647263, a novel EFNA4-ADC, in patients with metastatic triple negative breast cancer.
Garrido-Laguna I, Krop I, Burris H, Hamilton E, Braiteh F, Weise A, Abu-Khalaf M, Zopf C, Lakshminarayanan M, Holland J, Baffa R, Hong D, Hassan R. A phase I study of PF-06647263, a novel EFNA4-ADC, in patients with metastatic triple negative breast cancer. Journal Of Clinical Oncology 2017, 35: 2511-2511. DOI: 10.1200/jco.2017.35.15_suppl.2511.Peer-Reviewed Original ResearchTriple-negative breast cancerAdverse eventsNegative breast cancerExpansion cohortPartial responseBreast cancerMetastatic triple-negative breast cancerAnti-drug antibody developmentCommon adverse eventsDuration of treatmentAnti-tumor activityVivo preclinical studiesQ3w scheduleQW scheduleRECIST responseAdvanced malignanciesMucosal inflammationObjective responseDose escalationTNBC patientsTumor regressionTNBC modelsPreclinical studiesCommon treatmentPK data