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
2020
Translational Approach of Using Ex Vivo Cytotoxicity and Early Clinical Data to Predict Teclistamab Efficacious Therapeutic Range in Multiple Myeloma Patients
Girgis S, Lin S, Pillarisetti K, Banerjee A, Goldberg J, Shetty S, Stephenson T, Hilder B, Hanna B, Smit J, Adams H, Sun Y, Infante J, Elsayed Y, Sharma A. Translational Approach of Using Ex Vivo Cytotoxicity and Early Clinical Data to Predict Teclistamab Efficacious Therapeutic Range in Multiple Myeloma Patients. Blood 2020, 136: 35. DOI: 10.1182/blood-2020-140565.Peer-Reviewed Original ResearchMinimal anticipated biological effect levelCurrent equity holderEx vivo cytotoxicity assaysPhase 2 doseMM patientsBone marrow samplesTherapeutic rangeFIH studiesMultiple myelomaMarrow samplesMM cellsClinical dataCytotoxicity assayRecommended phase 2 doseRelapsed refractory MM patientsB-cell maturation antigenClinical starting doseExpression of BCMALow dose cohortRefractory MM patientsHigh tumor burdenPatient bone marrow samplesEx vivo cytotoxicityMalignant plasma cellsImmuno-oncology drugs
2019
ARV-110: An oral androgen receptor PROTAC degrader for prostate cancer.
Neklesa T, Snyder L, Willard R, Vitale N, Pizzano J, Gordon D, Bookbinder M, Macaluso J, Dong H, Ferraro C, Wang G, Wang J, Crews C, Houston J, Crew A, Taylor I. ARV-110: An oral androgen receptor PROTAC degrader for prostate cancer. Journal Of Clinical Oncology 2019, 37: 259-259. DOI: 10.1200/jco.2019.37.7_suppl.259.Peer-Reviewed Original ResearchAndrogen receptorAR degradationProstate cancerAR proteinAR target gene PSADegradation of ARCastration-resistant prostate cancerAR target gene expressionIND-enabling studiesMajority of patientsProstate cancer patientsMouse xenograft studiesPreclinical efficacy studiesProstate cancer modelMutant AR proteinAndrogen environmentMetastatic diseaseMost patientsAR signalingCancer patientsPreclinical dataAR pathwayMechanisms of resistanceLow nanomolar concentrationsFIH studies
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