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
2021
389 Phase II of CD40 agonistic antibody sotigalimab (APX005M) in combination with nivolumab in subjects with metastatic melanoma with confirmed disease progression on anti-PD-1 therapy
Weiss S, Sznol M, Shaheen M, Berciano-Guerrero M, Felip E, Rodríguez-Abreu D, Arance A, Boni V, Linette G, Schuchter L, Gonzalez-Cao M, Iannotti N, Ganti A, Hauke R, Berrocal A, Filbert E, Kluger H. 389 Phase II of CD40 agonistic antibody sotigalimab (APX005M) in combination with nivolumab in subjects with metastatic melanoma with confirmed disease progression on anti-PD-1 therapy. Journal For ImmunoTherapy Of Cancer 2021, 9: a422-a422. DOI: 10.1136/jitc-2021-sitc2021.389.Peer-Reviewed Original ResearchAnti-PD-1 therapyMelanoma patientsMetastatic melanomaTumor PD-L1 expressionEffective anti-tumor immunityArm phase II trialCD40 agonist antibodyRefractory melanoma patientsRefractory metastatic melanomaAdvanced melanoma patientsPD-1 blockadePD-L1 expressionPhase II trialAnti-tumor immunitySubset of patientsOverall safety profileMajority of AEsOptimal therapeutic applicationReceptor binding profileInstitutional review boardClinical study teamNebraska Medical CenterOpen labelII trialTolerability profile
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 IQ3wA phase II trial of dasatinib in advanced melanoma
Kluger H, Dudek A, McCann C, Rink L, Ritacco J, Adrada C, Phouyaphone N, Southard N, Sznol M. A phase II trial of dasatinib in advanced melanoma. Journal Of Clinical Oncology 2009, 27: 9010-9010. DOI: 10.1200/jco.2009.27.15_suppl.9010.Peer-Reviewed Original ResearchStarting dosePartial responseC-kitNon-cytotoxic therapiesPhase 2 trialPhase II trialSubset of patientsMelanoma cell proliferationCommon toxicitiesDaily dasatinibMucosal primaryPo bidPrior chemotherapyII trialClinical responseUnresectable melanomaAdvanced melanomaMedian agePleural effusionMinor responseGrade IITumor assessmentDose reductionPreclinical evaluationPatients