2019
661. Ibalizumab Efficacy and Safety Through 48 Weeks of Treatment: Results of an Expanded Access Protocol (TMB-311)
Emu B, DeJesus E, Berhe M, Leider J, Creticos C, Weinheimer S, Cohen Z. 661. Ibalizumab Efficacy and Safety Through 48 Weeks of Treatment: Results of an Expanded Access Protocol (TMB-311). Open Forum Infectious Diseases 2019, 6: s303-s303. PMCID: PMC6811265, DOI: 10.1093/ofid/ofz360.729.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsWeeks of treatmentCopies/mLViral loadCopies/Cohort 2Multidrug-resistant HIV-1 infectionDay 0HIV-1 RNA levelsImmune reconstitution inflammatory syndromeLog10 copies/mLHIV-1 viral loadPivotal phase 3 studiesCohort 2 patientsDurable viral suppressionMajor eligibility criteriaReconstitution inflammatory syndromeWeek 24 visitCD4 cell countMedian viral loadTreatment-experienced patientsCells/mm3Phase 3 studyInjection site reactionsLog10 copies/
2015
A phase I study of investigational agent SGI-110 combined with irinotecan in previously treated metastatic colorectal cancer patients.
Wang J, Gootjes E, Uram J, Zahurak M, El-Khoueiry A, Verheul H, Ahuja N, Azad N. A phase I study of investigational agent SGI-110 combined with irinotecan in previously treated metastatic colorectal cancer patients. Journal Of Clinical Oncology 2015, 33: tps797-tps797. DOI: 10.1200/jco.2015.33.3_suppl.tps797.Peer-Reviewed Original ResearchDose level 1SGI-110Colorectal cancerPhase ITumor biopsiesDay 1Metastatic colorectal cancer patientsRandomized phase II studyMajor eligibility criteriaPeriodic CT scansPhase II studyGrowth factor supportColorectal cancer patientsM2 days 1Metastatic colon adenocarcinomaMetastatic colon cancerCRC cell linesAdditional dose levelsEvaluation of biomarkersMeasureable diseaseTotal therapyII studyIrinotecan therapyDose escalationFactor support
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