2024
A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab, in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC).
Colevas A, Chung C, Adkins D, Rodriguez C, Park J, Gibson M, Sukari A, Worden F, Johnson F, Saba N, Burtness B, Julian R, Bauman J, Jotte R, Seiwert T, Dunn L, Chaney M, Margossian S, Levisetti M, Pai S. A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab, in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC). Journal Of Clinical Oncology 2024, 42: 6004-6004. DOI: 10.1200/jco.2024.42.16_suppl.6004.Peer-Reviewed Original ResearchCD8+ T cellsR/M HNSCCHuman leukocyte antigenT cellsMedian OSCheckpoint inhibitorsHLA-A*0201Adverse eventsInterleukin-2Combined cohortHead and neck squamous cell cancerE7-specific T cellsPhase 1 dose-escalationRecommended phase 2 doseTumor antigen-specific CD8First-in-human studyTargeted delivery of cytokinesHLA-A*0201 patientsPhase 2 doseDisease control rateGrade 3 AEsInfusion-related reactionsT-cell engagersSquamous cell cancerDelivery of cytokines
2020
Abstract LB-387: Efficacy and safety of AB928 plus modified FOLFOX-6 (mFOLFOX-6) in participants with metastatic colorectal cancer (mCRC): Initial results at the recommended dose for expansion (ARC-3)
Cecchini M, Modiano M, Braiteh F, Gardner O, Gilbert H, DiRenzo D, Seitz L, Walters M, Yin F, Woloski R, Paoloni M, Chung K. Abstract LB-387: Efficacy and safety of AB928 plus modified FOLFOX-6 (mFOLFOX-6) in participants with metastatic colorectal cancer (mCRC): Initial results at the recommended dose for expansion (ARC-3). Cancer Research 2020, 80: lb-387-lb-387. DOI: 10.1158/1538-7445.am2020-lb-387.Peer-Reviewed Original ResearchModified FOLFOX-6Metastatic colorectal cancerAdverse eventsPhase 1bFOLFOX-6Stable diseaseColorectal cancerAnti-tumor immune responseECOG performance status 0Recommended doseAssociated with disease controlExploratory biomarker analysesTumor shrinkage >Disease control rateDying cancer cellsGrade 3 AEsPerformance status 0Dose-escalation studyAdenosine receptor blockadeOpen-label studyAmerican Association for Cancer ResearchAdenosine receptor antagonistRelease of ATPNext gene sequencingAdenosine axis
2017
Successful Plerixafor-Mediated Mobilization, Apheresis, and Lentiviral Vector Transduction of Hematopoietic Stem Cells in Patients with Severe Sickle Cell Disease
Tisdale J, Pierciey F, Kamble R, Kanter J, Krishnamurti L, Kwiatkowski J, Thompson A, Shestopalov I, Bonner M, Joseney-Antoine M, Asmal M, Walters M. Successful Plerixafor-Mediated Mobilization, Apheresis, and Lentiviral Vector Transduction of Hematopoietic Stem Cells in Patients with Severe Sickle Cell Disease. Blood 2017, 130: 990. DOI: 10.1182/blood.v130.suppl_1.990.990.Peer-Reviewed Original ResearchSevere sickle cell diseaseSevere SCDPhase 1 studyBM harvestAutologous hematopoietic stem cellsSickle cell diseaseBone marrowBluebird BioHematopoietic stem cellsCell diseaseCultured CD34Cells/G-CSFPeak white blood cellAdvisory CommitteeMedical directorsHSC mobilizationGene therapyGrade 3 AEsPeripheral blood apheresisGroup B patientsAcceptable toxicity profileLife-threatening complicationsTotal blood volumeSteady-state bone marrowA phase II study of GDC-0032 (taselisib) for previously treated PI3K positive patients with stage IV squamous cell lung cancer (SqNSCLC): LUNG-MAP sub-study SWOG S1400B.
Wade J, Langer C, Redman M, Aggarwal C, Bradley J, Crawford J, Miao J, Griffin K, Herbst R, Kelly K, Gandara D, Papadimitrakopoulou V. A phase II study of GDC-0032 (taselisib) for previously treated PI3K positive patients with stage IV squamous cell lung cancer (SqNSCLC): LUNG-MAP sub-study SWOG S1400B. Journal Of Clinical Oncology 2017, 35: 9054-9054. DOI: 10.1200/jco.2017.35.15_suppl.9054.Peer-Reviewed Original ResearchPrimary endpointInterim analysisStage IV squamous cell lung cancerResponse rateSquamous cell lung cancerNational Clinical Trials NetworkSingle-arm phase II trialArm phase II trialGrade 3 AEsGrade 5 eventsPIK3CA-mutant tumorsPrimary analysis populationPhase II studyPhase II trialOverall survival dataCell lung cancerPlatinum-based therapyPrimary platinum-based therapyClinical Trials NetworkClinical trial informationPI3K mutationsPI3K pathwayEligible ptsMedian PFSStable diseasePhase II study of the FGFR inhibitor AZD4547 in previously treated patients with FGF pathway-activated stage IV squamous cell lung cancer (SqNSCLC): LUNG-MAP sub-study SWOG S1400D.
Aggarwal C, Redman M, Lara P, Borghaei H, Hoffman P, Bradley J, Griffin K, Miao J, Mack P, Papadimitrakopoulou V, Herbst R, Kelly K, Gandara D. Phase II study of the FGFR inhibitor AZD4547 in previously treated patients with FGF pathway-activated stage IV squamous cell lung cancer (SqNSCLC): LUNG-MAP sub-study SWOG S1400D. Journal Of Clinical Oncology 2017, 35: 9055-9055. DOI: 10.1200/jco.2017.35.15_suppl.9055.Peer-Reviewed Original ResearchOverall response rateProgression-free survivalFGFR inhibitor AZD4547Eligible ptsFGFR3 S249CStage IV squamous cell lung cancerAdequate end-organ functionMedian progression-free survivalSquamous cell lung cancerFirst phase II trialGrade 3 AEsGrade 4 sepsisGrade 5 AEsPhase II studyAcceptable safety profileEmergence of immunotherapyEnd-organ functionPhase II trialCell lung cancerDuration of responseEvaluable ptsMeasurable diseaseUnconfirmed PRII trialPrimary endpoint
2014
Src inhibition through a phase II study of 5-fluorouracil, oxaliplatin, plus dasatinib (FOLFOX-D) in first-line metastatic pancreatic adenocarcinoma.
George T, Ivey A, Daily K, Dang L, Watson S, Granicz R, Tormes K, Lu X, Liu C, Allegra C, Behrns K, Hughes S, Ogunwobi O, Trevino J. Src inhibition through a phase II study of 5-fluorouracil, oxaliplatin, plus dasatinib (FOLFOX-D) in first-line metastatic pancreatic adenocarcinoma. Journal Of Clinical Oncology 2014, 32: 319-319. DOI: 10.1200/jco.2014.32.3_suppl.319.Peer-Reviewed Original ResearchMetastatic pancreatic cancerProgression-free survivalGrade 3 AEsOverall survivalOral multi-tyrosine kinase inhibitorMedian progression-free survivalMulti-tyrosine kinase inhibitorSrc inhibitionAdequate organ functionBiochemical response rateECOG PS 0Grade 4 AEsGrade 5 toxicityRECIST measurable diseaseTriplet combination therapyPhase II studyMetastatic pancreatic adenocarcinomaClinical unmet needPredictors of responseQuality of lifeEligible ptsMFOLFOX6 chemotherapyMeasurable diseasePrior therapySecondary endpoints
2006
Preliminary results of a randomized placebo-controlled double-blind trial of weekly docetaxel combined with imatinib in men with metastatic androgen-independent prostate cancer (AIPC) and bone metastases (BM)
Mathew P, Thall P, Johnson M, Oh W, Meluch A, Morris M, Troncoso P, Bucana C, Fidler I, Logothetis C. Preliminary results of a randomized placebo-controlled double-blind trial of weekly docetaxel combined with imatinib in men with metastatic androgen-independent prostate cancer (AIPC) and bone metastases (BM). Journal Of Clinical Oncology 2006, 24: 4562-4562. DOI: 10.1200/jco.2006.24.18_suppl.4562.Peer-Reviewed Original ResearchAndrogen-independent prostate cancerTime to progressionBone metastasesPlatelet-derived growth factor receptorPartial responseProgressive androgen-independent prostate cancerMetastatic androgen-independent prostate cancerHigh-dose steroid useMedian time to progressionRandomized placebo-controlled double-blind trialGrade 3 AEsMedian overall survivalBone marrow biopsyECOG performance scoreGastrointestinal adverse eventsPerforated sigmoid diverticulitisGrowth factor receptorPerformance scoresWeekly docetaxelProgression-FreeStable diseaseMarrow biopsyTumor responseSigmoid diverticulitisDocetaxel activity
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