2024
Entinostat, nivolumab and ipilimumab for women with advanced HER2-negative breast cancer: a phase Ib trial
Roussos Torres E, Ho W, Danilova L, Tandurella J, Leatherman J, Rafie C, Wang C, Brufsky A, LoRusso P, Chung V, Yuan Y, Downs M, O’Connor A, Shin S, Hernandez A, Engle E, Piekarz R, Streicher H, Talebi Z, Rudek M, Zhu Q, Anders R, Cimino-Mathews A, Fertig E, Jaffee E, Stearns V, Connolly R. Entinostat, nivolumab and ipilimumab for women with advanced HER2-negative breast cancer: a phase Ib trial. Nature Cancer 2024, 5: 866-879. PMID: 38355777, PMCID: PMC11552660, DOI: 10.1038/s43018-024-00729-w.Peer-Reviewed Original ResearchHormone receptor-positive breast cancerReceptor-positive breast cancerTriple-negative breast cancerClinical benefit rateProgression-free survivalBreast cancerBenefit rateAdvanced HER2-negative breast cancerAdvanced triple-negative breast cancerHER2-negative breast cancerResponse rateNivolumab + ipilimumabPD-L1 statusDose-limiting toxicityPhase Ib trialTumor mutational burdenPhase II trialDose escalationExpansion cohortPD-L1II trialMutational burdenPrimary endpointSecondary endpointsMyeloid cells
2023
CBX-12-101: A first-in-human study of CBX-12, an alphalex peptide drug conjugate (PDC) in patients (pts) with advanced or metastatic solid tumors.
Rodriguez Rivera I, Hafez N, Tolcher A, LoRusso P, Wilks S, Tripathy D, Gara M, Pearson P, DeCillis A, Meric-Bernstam F. CBX-12-101: A first-in-human study of CBX-12, an alphalex peptide drug conjugate (PDC) in patients (pts) with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2023, 41: 3087-3087. DOI: 10.1200/jco.2023.41.16_suppl.3087.Peer-Reviewed Original ResearchTreatment-related AEsOvarian cancerBreast cancerFrequent treatment-related AEsHER2-negative breast cancerPlatinum-resistant ovarian cancerDaily x 3Daily x 5Hormone receptor positiveSingle-agent antitumor activityMetastatic solid tumorsPhase 1 trialAnti-drug antibodiesNegative breast cancerAnti-tumor activityAntibody-drug conjugatesFebrile neutropeniaRECIST v1.1WBC decreaseExpansion cohortFIH studiesPlasma PKTumor cell membranesHuman studiesSolid tumors
2021
A phase Ib study of xentuzumab plus abemaciclib and fulvestrant in patients (pts) with advanced hormone receptor-positive (HR+), HER2-negative breast cancer (BC) with visceral or non-visceral disease.
Yee D, LoRusso P, Sablin M, Prat A, Stradella A, Utriainen M, Oliveira M, Yonemori K, Naito Y, Hardebeck M, Puig M, Hu J, Biyukov T, Iwata H. A phase Ib study of xentuzumab plus abemaciclib and fulvestrant in patients (pts) with advanced hormone receptor-positive (HR+), HER2-negative breast cancer (BC) with visceral or non-visceral disease. Journal Of Clinical Oncology 2021, 39: 1057-1057. DOI: 10.1200/jco.2021.39.15_suppl.1057.Peer-Reviewed Original ResearchDisease control rateNon-visceral diseaseEndocrine therapyBreast cancerVisceral metastasesProgression-free survival benefitHER2-negative breast cancerDisease controlDose-finding cohortMost common AEsMedian treatment durationOpen-label studyPhase Ib studyPhase II doseNon-measurable diseaseHypo/hyperglycemiaCyclin-dependent kinase 4Advanced hormoneCommon AEsPFS ratesExpansion cohortPostmenopausal womenPrimary endpointSecondary endpointsMedian duration
2019
343P Phase I dose escalation study of a selective androgen receptor modulator RAD140 in estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer (BC)
Hamilton E, Vidula N, Ma C, LoRusso P, Bagley R, Yu Z, Annett M, Weitzman A, Conlan M, Weise A. 343P Phase I dose escalation study of a selective androgen receptor modulator RAD140 in estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer (BC). Annals Of Oncology 2019, 30: v123. DOI: 10.1093/annonc/mdz242.038.Peer-Reviewed Original ResearchProstate-specific antigenSelective AR modulatorsALT/ASTBreast cancerMetastatic BCRadius HealthAndrogen receptorHER2-negative breast cancerSerum prostate-specific antigenAR agonist activityGenentech/RocheWeight/appetiteAntitumor activityFrequent adverse eventsAcceptable safety profileKey eligibility criteriaMetastatic breast cancerPhase 1 studyHormone-binding globulinAndrogen-responsive tissuesDrug-related deathsNegative breast cancerBristol-Myers SquibbFlatiron HealthStable disease
2017
90TiP A phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumors, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/- endocrine therapy), or non-small-cell lung cancer (NSCLC)
Yee D, Prat A, Sablin M, Iwata H, Johnston E, Bogenrieder T, Serra J, Hua H, LoRusso P. 90TiP A phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumors, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/- endocrine therapy), or non-small-cell lung cancer (NSCLC). Annals Of Oncology 2017, 28: x25. DOI: 10.1093/annonc/mdx656.001.Peer-Reviewed Original Research235TiP A Phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumours, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/-endocrine therapy), or non-small-cell lung cancer (NSCLC)
Prat A, Yee D, Sablin M, Iwata H, Johnston E, Bogenrieder T, Serra J, Stucke-Straub K, Russo P. 235TiP A Phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumours, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/-endocrine therapy), or non-small-cell lung cancer (NSCLC). Annals Of Oncology 2017, 28: v72-v73. DOI: 10.1093/annonc/mdx364.017.Peer-Reviewed Original Research