2024
The HER2-directed antibody-drug conjugate DHES0815A in advanced and/or metastatic breast cancer: preclinical characterization and phase 1 trial results
Lewis G, Li G, Guo J, Yu S, Fields C, Lee G, Zhang D, Dragovich P, Pillow T, Wei B, Sadowsky J, Leipold D, Wilson T, Kamath A, Mamounas M, Lee M, Saad O, Choeurng V, Ungewickell A, Monemi S, Crocker L, Kalinsky K, Modi S, Jung K, Hamilton E, LoRusso P, Krop I, Schutten M, Commerford R, Sliwkowski M, Cho E. The HER2-directed antibody-drug conjugate DHES0815A in advanced and/or metastatic breast cancer: preclinical characterization and phase 1 trial results. Nature Communications 2024, 15: 466. PMID: 38212321, PMCID: PMC10784567, DOI: 10.1038/s41467-023-44533-z.Peer-Reviewed Original ResearchConceptsHER2 antibody-drug conjugatesAntibody-drug conjugatesMetastatic breast cancerPhase 1 trialBreast cancerHER2-positive metastatic breast cancerHER2-positive breast cancerObjective response rateDose-escalation studyDuration of responseModel of HER2Anti-tumor activityMechanism of actionTrastuzumab deruxtecanPulmonary toxicityTrastuzumab emtansinePreclinical characterizationResponse rateHigh dosesVivo efficacySecondary objectiveEarly signsPotent cytotoxic agentCytotoxic agentsCancer
2016
Antibody–Drug Conjugates (ADCs) in Clinical Development
McLaughlin J, LoRusso P. Antibody–Drug Conjugates (ADCs) in Clinical Development. 2016, 321-344. DOI: 10.1002/9781119060727.ch13.Peer-Reviewed Original ResearchAntibody-drug conjugatesCytotoxic agentsMonoclonal antibodiesLocal immune responseFavorable safety profileConventional cytotoxic chemotherapyConventional cytotoxic agentsDifferent antibody–drug conjugatesImmune-stimulating agentsAnti-neoplastic agentsCytotoxic chemotherapySafety profileCancer patientsIL-2Clinical trialsImmune responseClinical developmentOncologist's abilityImproved efficacyPhase IDrug conjugatesAntibodiesEfficacyTarget effectsToxicity
2013
Predictive value of phase I trials for safety and final approved dose in later trials: Analysis of 33,845 patients.
Fontes Jardim D, Hess K, LoRusso P, Kurzrock R, Hong D. Predictive value of phase I trials for safety and final approved dose in later trials: Analysis of 33,845 patients. Journal Of Clinical Oncology 2013, 31: 2509-2509. DOI: 10.1200/jco.2013.31.15_suppl.2509.Peer-Reviewed Original ResearchDose-limiting toxicityMultiple logistic regression analysisDeath rateLater trialsPhase IPhase II doseRelevant side effectsDose of agentDrug Administration websiteLogistic regression analysisChi-squared testAdverse eventsMultivariable analysisSafety profileFinal doseGrade 3Oral drugsNew agentsSide effectsPackage insertsPredictive valueUS FoodRegistration trialsCytotoxic agentsSignificant toxicity
2012
Oral Chemotherapeutic Agents
Ogita S, LoRusso P, Li J. Oral Chemotherapeutic Agents. 2012, 1-37. DOI: 10.1002/9780470921920.edm132.Peer-Reviewed Original ResearchOral chemotherapeutic agentsInterindividual pharmacokinetic variabilityChemotherapeutic agentsPharmacokinetic variabilityImmune-modulating agentsTraditional cytotoxic agentsFirst-pass metabolismClass of agentsCytochrome P450 3A4Mechanism of actionAntiacid medicationOral agentsConcomitant administrationIntestinal effluxHormonal agentsIntravenous agentsFood effectDrug dispositionABCB1 transporterDrug resistanceClinical useCytotoxic agentsStaff time savingsP450 3A4Noninvasive administration