2023
Mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose expansion results.
Carneiro B, Perets R, Dowlati A, LoRusso P, Yonemori K, He L, Munasinghe W, Noorani B, Johnson E, Zugazagoitia J. Mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose expansion results. Journal Of Clinical Oncology 2023, 41: 3027-3027. DOI: 10.1200/jco.2023.41.16_suppl.3027.Peer-Reviewed Original ResearchNon-small cell lung cancerSmall cell lung cancerOverall response rateCommon adverse eventsRefractory solid tumorsCell lung cancerSCLC cohortBest overall responseAdverse eventsMonotherapy cohortTaxane therapyLung cancerSolid tumorsConfirmed overall response rateDose-expansion phaseOngoing phase 1Phase 2 dosePrior taxane therapyTolerable safety profileDisease control rateGrade 3/4 neutropeniaOpen-label studyDose-escalation phasePhase 1 studySingle-agent activity
2021
A first-in-human study of mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose escalation results.
Tolcher A, Carneiro B, Dowlati A, Razak A, Chae Y, Villella J, Coppola S, Englert S, Phillips A, Souers A, Salman Z, Penugonda S, Powderly J, LoRusso P. A first-in-human study of mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose escalation results. Journal Of Clinical Oncology 2021, 39: 3015-3015. DOI: 10.1200/jco.2021.39.15_suppl.3015.Peer-Reviewed Original ResearchRefractory solid tumorsAdverse eventsCell lung cancerSolid tumorsLymphocyte countLung cancerNon-small cell lung cancerSmall cell lung cancerMedian age 62 yearsCommon adverse eventsDose-expansion phasePhase 2 dosePrior systemic therapyTolerable safety profileFatal adverse eventsFatal cardiac arrestOverall response rateAge 62 yearsDose-escalation resultsAnti-tumor activityECOG 0ECOG 1RECIST v1.1Taxane therapyMedian durationSafety and efficacy of the anti-CD73 monoclonal antibody (mAb) oleclumab ± durvalumab in patients (pts) with advanced colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), or EGFR-mutant non-small cell lung cancer (EGFRm NSCLC).
Bendell J, LoRusso P, Overman M, Noonan A, Kim D, Strickler J, Kim S, Clarke S, George T, Grimison P, Barve M, Amin M, Desai J, Wise-Draper T, Cooper Z, Elgeioushi N, Mueller N, Kumar R, Wu K, Patel S. Safety and efficacy of the anti-CD73 monoclonal antibody (mAb) oleclumab ± durvalumab in patients (pts) with advanced colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), or EGFR-mutant non-small cell lung cancer (EGFRm NSCLC). Journal Of Clinical Oncology 2021, 39: 9047-9047. DOI: 10.1200/jco.2021.39.15_suppl.9047.Peer-Reviewed Original ResearchTreatment-related adverse eventsPancreatic ductal adenocarcinomaCommon treatment-related adverse eventsAdvanced colorectal cancerObjective responseCombination therapyColorectal cancerEGFRm NSCLCEscalation phaseNSCLC ptsEGFR-mutant non-small cell lung cancerNon-small cell lung cancerMicrosatellite stable colorectal cancerTolerable safety profileUpregulation of CD73Cell lung cancerDuration of responseStable colorectal cancerRECIST v1.1Expansion cohortPrevious interim analysisClinical responseData cutoffLocal immunosuppressionManageable safety
2019
First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors
Piha-Paul SA, Sachdev JC, Barve M, LoRusso P, Szmulewitz R, Patel SP, Lara PN, Chen X, Hu B, Freise KJ, Modi D, Sood A, Hutti JE, Wolff J, O'Neil BH. First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors. Clinical Cancer Research 2019, 25: 6309-6319. PMID: 31420359, DOI: 10.1158/1078-0432.ccr-19-0578.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsDose escalationSolid tumorsStable diseaseSafety profileProstate cancerCommon grade 3/4 treatment-emergent adverse eventsGrade 3/4 treatment-emergent adverse eventsHuman studiesMost common treatment-emergent adverse eventsCommon treatment-emergent adverse eventsMedian progression-free survivalTolerable safety profilePhase II doseAdvanced solid tumorsProgression-free survivalRefractory solid tumorsPreliminary antitumor activityMalignant solid tumorsAminotransferase elevationEvaluable patientsDose expansionExpansion cohortGastrointestinal bleedAdverse events