2023
A Phase II Trial of the CD40 Agonist Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Disease Progression on Anti-PD-1
Weiss S, Sznol M, Shaheen M, Berciano-Guerrero M, Muñoz-Couselo E, Rodríguez-Abreu D, Boni V, Schuchter L, Cao M, Fernandez A, Wei W, Ganti A, Hauke R, Berrocal A, Iannotti N, Hsu F, Kluger H. A Phase II Trial of the CD40 Agonist Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Disease Progression on Anti-PD-1. Clinical Cancer Research 2023, 30: 74-81. PMID: 37535056, PMCID: PMC10767304, DOI: 10.1158/1078-0432.ccr-23-0475.Peer-Reviewed Original ResearchConceptsObjective response ratePhase II trialAdverse eventsPartial responseDisease progressionII trialGrade 3 adverse eventsAnti PD-1CD40 agonist antibodyElevated liver functionTreatment-related SAEsCommon adverse eventsActivation of CD40Subset of patientsFavorable safety profileAntigen presenting cellsStable diseaseMedian durationAdvanced melanomaAdditional patientsLiver functionSafety profileMetastatic melanomaPreclinical dataPresenting cells
2009
Pharmacokinetics (PK) of CR011-vcMMAE, an antibody-drug conjugate (ADC), in a phase (Ph) I study of patients (pts) with advanced melanoma
Sznol M, Hamid O, Hwu P, Kluger H, Hawthorne T, Crowley E, Simantov R, Pavlick A. Pharmacokinetics (PK) of CR011-vcMMAE, an antibody-drug conjugate (ADC), in a phase (Ph) I study of patients (pts) with advanced melanoma. Journal Of Clinical Oncology 2009, 27: 9063-9063. DOI: 10.1200/jco.2009.27.15_suppl.9063.Peer-Reviewed Original ResearchAntibody-drug conjugatesCR011-vcMMAETotal AbAdverse eventsMean maximum plasma concentrationNoncompartmental PK analysisCommon adverse eventsMaximum plasma concentrationEnzyme-linked immunosorbent assayQ3w scheduleQW scheduleII trialWeekly dosingAdvanced melanomaDose escalationDose scheduleCumulative dosesPK analysisPlasma concentrationsBreast cancerImmunosorbent assayPhase IPharmacokineticsPH IQ3w